Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

Users Online : 14900

AbstractMaterial and MethodsResultsDiscussionConclusionReferencesDOI and Others
Article in PDF How to Cite Citation Manager Readers' Comments (0) Audio Visual Article Statistics Link to PUBMED Print this Article Send to a Friend
Advertisers Access Statistics Resources

Dr Mohan Z Mani

"Thank you very much for having published my article in record time.I would like to compliment you and your entire staff for your promptness, courtesy, and willingness to be customer friendly, which is quite unusual.I was given your reference by a colleague in pathology,and was able to directly phone your editorial office for clarifications.I would particularly like to thank the publication managers and the Assistant Editor who were following up my article. I would also like to thank you for adjusting the money I paid initially into payment for my modified article,and refunding the balance.
I wish all success to your journal and look forward to sending you any suitable similar article in future"



Dr Mohan Z Mani,
Professor & Head,
Department of Dermatolgy,
Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



Dr Kalyani R
Professor and Head
Department of Pathology
Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
As an experienced dentist and an academician, I proudly recommend this journal to the dental fraternity as a good quality open access platform for rapid communication of their cutting-edge research progress and discovery.
I wish JCDR a great success and I hope that journal will soar higher with the passing time."



Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2023 | Month : January | Volume : 17 | Issue : 1 | Page : UC23 - UC26 Full Version

Comparison of Analgesic Efficacy of Nalbuphine and Fentanyl as Adjuvants to Intrathecal Hyperbaric Bupivacaine in Patients undergoing Lower Limb Orthopaedic Surgeries: Randomised Clinical Trial


Published: January 1, 2023 | DOI: https://doi.org/10.7860/JCDR/2023/60810.17365
Vijay V Katti, NR Swathi, Renuka Holyachi

1. Associate Professor, Department of Anaesthesiology, BLDEDU Shri BM Patil Medical College, Vijayapur, Karnataka, India. 2. Junior Resident, Department of Anaesthesiology, BLDEDU Shri BM Patil Medical College, Vijayapur, Karnataka, India. 3. Professor, Department of Anaesthesiology, BLDEDU Shri BM Patil Medical College, Vijayapur, Karnataka, India.

Correspondence Address :
Dr. Vijay V Katti,
Associate Professor, Department of Anaesthesiology,
BLDEDU Shri BM Patil Medical College, Vijayapur, Karnataka, India.
E-mail: drvijaykatti@gmail.com

Abstract

Introduction: Postoperative pain management poses a major challenge in patients who undergo lower limb orthopaedic surgeries. Methods that reduce the requirements of systemic analgesics and have minimal adverse effects on haemodynamic stability are the need of the hour. Nalbuphine, a kappa agonist/partial μ antagonist can be utilised in spinal anaesthesia as an auxiliary to local anaesthetic.

Aim: To evaluate the efficiency of intrathecal hyperbaric bupivacaine versus nalbuphine plus fentanyl as adjuvants in patients undergoing lower limb orthopaedic surgeries.

Materials and Methods: This prospective randomised clinical trial comprised 70 American Society of Anaesthesiologists (ASA) grade I and II patients aged between 18 to 60 years who had been posted for elective lower limb orthopaedic operations. Patients were randomly assigned to either Group NB (intrathecal bupivacaine with nalbuphine) or Group FB (Intrathecal bupivacaine with fentanyl). Onset and duration of sensory and motor block, haemodynamic alterations, side-effects, and requirement for systemic analgesics in the postoperative period were examined.

Results: There was no statistically significant difference in beginning of sensory and motor blockage between the two groups. In comparison to group FB, group NB’s sensory blockade lasted substantially longer (126.06±6.52 minutes vs. 103.34±3.7 minutes; p-value<0.001). In group NB, the length of the motor block was considerably longer (p-value<0.001). When compared to patients in group FB (230.83±7.98 minutes), patients in group NB experienced analgesia for a mean time of 278.31±9.58 minutes, which was noticeably longer. There was no discernible difference between group NB and group FB (p-value>0.05) in terms of symptoms such as nausea, vomiting, bradycardia, and hypotension throughout the intraoperative period.

Conclusion: In patients scheduled for elective lower limb orthopaedic procedures, intrathecal nalbuphine 1 mg as an adjuvant to 0.5% hyperbaric bupivacaine for subarachnoid block extend the duration of sensory block, motor block, and the postoperative analgesia more successfully than intrathecal fentanyl 25 μg.

Keywords

Central neuraxial block, Haemodynamic stability, Motor block, Sensory block

Spinal anaesthesia is a common modality used for surgeries below the hip. Single-shot spinal anaesthesia though technically feasible and cost-effective, especially in settings of limited resources, comes with the disadvantage of a shorter duration of action of local anaesthetic, which may not suffice in the postoperative period (1),(2). The use of systemic analgesics like opioids, Non Steroidal Anti-Inflammatory Drugs (NSAIDs), and acetaminophen forms part of multimodal analgesia. Still, an effective intrathecal adjuvant to local anaesthetic with minimum adverse effects would be more advantageous. Spinal anaesthesia frequently involves the use of hyperbaric bupivacaine. Action lasts between two and four hours. Adding intrathecal opioids to local anaesthetics prolongs the time that postoperative analgesia lasts (2). An opioid with a rapid onset of effect following intrathecal injection is fentanyl. It does not diffuse to fourth ventricle with enough concentration when administered intrathecally to cause delayed respiratory depression. Without influencing sympathetic block, it generates synergistic analgesia for somatic and visceral pain (3). Nalbuphine is a lipophilic semisynthetic opioid with a relatively potent μ-antagonist and κ-agonist activity. κ-opioid receptors that regulate nociception are found across the brain and spinal cord. Nalbuphine produces analgesia by attaching to κ-receptors in the brain. Nalbuphine’s μ-antagonist characteristics contribute to fewer adverse events such as respiratory depression, itching, nausea, and vomiting (4). Adding nalbuphine to intrathecal bupivacaine maintain sensory block and better postoperative analgesia, according to studies, without exacerbating adverse effects or untoward complications (3),(4).

Patients undergoing elective lower limb orthopaedic procedures, the current study compared the effectiveness of intrathecal nalbuphine and fentanyl as adjuvants to hyperbaric bupivacaine. Main aim was to evaluate the effectiveness of 25 μg of fentanyl and 1 mg of nalbuphine as adjuvants to intrathecal 0.5% hyperbaric bupivacaine. Onset and duration of the sensory and motor blockage were the outcome measures. Studying intraoperative haemodynamic changes and adverse effects such pruritis, nausea, vomiting, respiratory depression, bradycardia, and hypotension was the secondary goal.

Material and Methods

The present randomised clinical trial was carried from January 2020 to September 2021 at the BLDEDU Shri BM Patil Medical College Hospital and Research Centre, Vijayapur, Karnataka, India. Approval was obtained from the Institutional Ethical Committee (IEC) (IEC/No-131/2019). The study was entered into the CTRI/2021/05/033463 clinical trial registry in India. The participants gave their informed consent to be a part of study.

Inclusion criteria: A total of 70 patients with ASA grades 1 and 2 between ages of 18 and 60 who were scheduled to have elective lower limb orthopaedic procedures under the subarachnoid block were included in the study.

Exclusion criteria: Patients with known allergies to study medicines or contraindications to spinal anaesthesia were excluded from in the trial.

Sample size calculation: The formula used to determine sample size was n = f(α/2, β) × 2 × σ2 / (μ1 - μ2)2, where μ1 and μ2 were the mean outcome in the study groups respectively, σ is standard deviation. To achieve a two-tailed significance level of 5% and 80% power of detection of an increase in analgesic duration, a sample size of 60 was estimated.

Haemodynamic parameters noted at 0, 5, 10, 15, 30, 60 and 120 minutes.

Modified Bromage Scale (1):

• Able to raise leg straight, full flexion of knees and feet.
• Inability to raise the leg, just able to flex knees, full flexion of feet.
• Unable to flex knees, but some flexion of feet possible.
• Unable to move the legs or feet.

Visual Analogue Scale (VAS) was used to measure the pain. Patients were given a scale with numbers ranging from 0 to 10 and asked to indicate on the scale how much pain they are currently feeling, from 0 (no pain) to 10 (worst pain possible). When VAS was greater than 3, diclofenac sodium 1.5 mg/kg IV infusion was administered to provide rescue analgesia, and the duration of the rescue analgesia was recorded. Side-effects like pruritis, nausea, vomiting, respiratory depression, bradycardia and hypotension were monitored. Atropine injections of 0.6 mg intravenously were to be used to treat bradycardia, which was defined as a 20% reduction in PR from the baseline PR. A bolus dose of 3 mg of injectable mephentermine was to be used to treat hypotension, which defined as a 20% drop in BP from basal values.

Statistical Analysis

Frequencies and proportions served as the representation for categorical data. Mean and standard deviation used to depict continuous data. For qualitative data, the Chi-square test was utilised. To determine mean difference between the variables, the independent t-test was employed as a measure of significance. Statistics were considered significant if p-value<0.05.

Results

Both groups were compared on various demographic variables like age, gender distribution, body mass index and ASA grades. There was no significant difference observed (Table/Fig 2).

There was no statistically significant difference between patients in group NB and group FB regarding the time at which sensory blockade began (onset; 178±14.97 vs. 174.4±12.57 seconds; p-value=0.28). There was no statistically significant difference between the two groups in the average time from the commencement of motor block to Bromage grade 3 (318.09±13.36 seconds in group NB and 322.23± 16.29 seconds in group FB). It was statistically significant that mean time for sensory block in groups NB and FB was 126.06± 6.52 minutes and 103.34± 3.7 minutes, respectively. With a p-value of <0.001, patients in group NB had a motor block for a mean time that was substantially longer than those in group FB (135.43± 6.63 minutes) (Table/Fig 3).

Haemodynamic parameters like Heart Rate (HR), Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) in group NB and group FB at 0, 5, 10, 15, 30, 60 and 120 minutes intervals during intraoperative and postoperative, periods were comparable. There were no significant changes between the two groups. Occurrences of side-effects like nausea, vomiting, bradycardia and hypotension during the intraoperative period were minimal, and there was no significant difference (p>0.05) between group NB and group FB (Table/Fig 4).

In this study, there was no significant difference in mean VAS score between the two groups from 0 to 2 hours, but at 4 hours, the mean VAS score was higher in group FB than in group NB (Table/Fig 5).

Discussion

Subarachnoid block has been used extensively in lower limb procedures. Subarachnoid block with local anaesthetics alone has a shorter duration of postoperative analgesia. To enhance postoperative analgesia, opioid additives such as fentanyl, morphine and buprenorphine have been explored (5),(6),(7). Intrathecal opioids can give longer-lasting postoperative analgesia, causing fewer negative effects than systemic opioids (8),(9). The commonly administered opioids are agonist agents with extremely good analgesic efficacy but with a variety of μ accompanying adverse effects. Later, it was found that significant analgesia may get induced interacting with κ-binding sites without having any adverse effects associated with it (10),(11). The main benefit is selective pain blockade without considerable sympathetic and motor block, allowing for greater haemodynamic stability. There were studies on opioids like nalbuphine, a κ agonist/partial μ antagonist analgesic (12), as an adjuvant in spinal anaesthesia. The goal of the current randomised comparative trial was to evaluate the effectiveness of 0.5% hyperbaric bupivacaine and intrathecal nalbuphine 1 mg and fentanyl 25 μg as adjuvants in patients posted for elective lower limb surgeries. In patients scheduled for elective lower limb orthopaedic surgeries, it was found that intrathecal nalbuphine 1 mg as an adjuvant to 0.5% hyperbaric bupivacaine for subarachnoid block prolongs the duration of sensory block, motor block, and the postoperative analgesia more effectively than intrathecal fentanyl 25 μg.

Nalbuphine was compared to intrathecal morphine at doses of 0.2 mg, 0.8 mg, and 1.6 mg by Culebras X et al., (13), who found that intrathecal nalbuphine 0.8 mg provide more effective intraoperative and early pain relief with no side-effects. Additionally, they found that increasing the intrathecal nalbuphine dose in this group to 1.6 mg did not improve analgesic effects but did increase unfavourable effects. It asserts that increasing the dosage of nalbuphine only slightly improves its analgesic effects upto a point and then has no further effect. Nalbuphine 1 mg was used in this study to compare to fentanyl 25 μg.

In this current study, the onset of sensory block was comparable in group NB (178±14.97 seconds) and group FB (174.4±12.57 seconds), and there was no significant difference between the two groups in terms of reaching the T8 sensory block level (p-value=0.280). In the Gomaa HM et al., study there was hardly any significant variation in the initiation of the sensory block between the fentanyl and nalbuphine groups compared to intrathecal nalbuphine 0.8 mg and fentanyl 25 μg (14). Similarly, Gupta K et al., also reported no statistically difference among nalbuphine and fentanyl groups (15). Mean time for motor block development in group NB was found 318.09±13.36 seconds compared to 322.23±16.29 seconds in group FB, which was not statistically significant (p-value=0.249). Both Gupta K et al., (15) and Bindra TK et al., (16) found hardly any statistically significant differences in two groups in the start of motor blockage. However, Gomaa HM et al., (14) found that onset of motor block with fentanyl was noticeably quicker than with nalbuphine.

In present study, the mean duration of sensory block was longer (126.06±6.52 minutes) in patients of group NB than in patients of group FB (103.34±3.7 minutes), and it was statistically significant (p-value <0.001). Gupta K et al., and Gurunath BB and Madhusudhana R in their study discovered that time of two-segment sensory regression test in nalbuphine group was much longer than in the fentanyl group (15),(17). Duration of motor block in patients of group NB (156.66±9.31 minutes) was more than that of group FB (135.43 ±6.63 minutes), which was statistically significant (p-value <0.001). Ahluwalia P et al., also found that the nalbuphine group had a prolonged duration of motor block compared to the fentanyl group (18).

Duration of analgesia was substantially longer for patients in this trial who had received intrathecal nalbuphine 1 mg as an adjuvant than for the individuals who received intrathecal fentanyl 25 μg (p-value<0.001). In group NB, mean time of analgesia was 278.31± 9.58 minutes; in group FB, it was 230.83±7.98 minutes. Tiwari AK et al., observed that nalbuphine was statistically significant and had a longer analgesic duration than fentanyl (19). Gomaa HM et al. Study on comparison of postoperative analgesia between intrathecal fentanyl 25 μg and nalbuphine 0.8 mg found that the nalbuphine group’s analgesia was prolonged but that there was no statistically significant difference between the two groups.

At intervals of 0, 5, 10, 15, 30, 60, and 120 minutes, there was no statistically significant difference between the two groups in vital signs such heart rate, systolic blood pressure, and diastolic blood pressure. In this study, there was no any significant difference in mean VAS score between two groups from 0 to 2 hours. At 4 hours mean VAS Score was higher in group FB compared to group NB. Bindra TK et al., found that in the nalbuphine group, the mean VAS score for postoperative pain was lesser than in the fentanyl group (16). Mostafa MG et al., and Naaz S et al., found patients who received intrathecal nalbuphine required a much smaller amount of rescue analgesics (20),(21).

Side-effects such as pruritis, nausea, vomiting, respiratory depression, bradycardia and hypotension following administration of spinal anaesthesia with the above intrathecal opioids were minimal in both the groups and did not differ much among the two groups and were statistically not significant. In a study by Singh N et al., by combining nalbuphine with intrathecal bupivacaine, were able to maintain sensory block, postoperative analgesia without any negative side-effects or problems (22). When Gurunath and Madhusudhana R compared intrathecal nalbuphine to fentanyl as a good spinal adjuvant, they discovered that nalbuphine users experienced less side-effects than fentanyl (17).

Limitation(s)

Since the present study was done in only elective lower limb orthopaedic surgeries, the observations and results of the study cannot be generalised for emergency surgeries.

Conclusion

Patients scheduled for elective lower limb orthopaedic procedures, intrathecal nalbuphine 1 mg as an adjuvant to 0.5% hyperbaric bupivacaine for subarachnoid block prolongs duration of sensory block, motor block, and postoperative analgesia more successfully than intrathecal fentanyl 25 μg.

References

1.
Paul G Barash, Bruce F Cullen: Clinical Anaesthesia, 6 th edition: Lippincott, Williams and Wilkins: 2006: 700-06.
2.
Shaikh SI, Kiran M. Intrathecal buprenorphine for postoperative analgesia: A prospective randomized, double-blind study. J Anaesth Clin Pharmacol. 2010;26:35-38. [crossref]
3.
Hamber EA, Viscomi CM. Intrathecal lipophilic opioids as adjuncts to surgical spinal anesthesia. Reg Anesth Pain Med. 1999; 24(3):255-63. [crossref]
4.
Eisenach JC, Carpenter R, Curry R. Analgesia from a peripherally active kappa- opioid receptor agonist in patients with chronic pancreatitis. Pain. 2003; 101(1- 2):89-95. [crossref] [PubMed]
5.
Dakhla GN, Hiware SK, Shinde AT, Mahatme MS. Basic biostatistics for post- graduate students. Indian J Pharmacol. 2012;44(4):435-42. [crossref] [PubMed]
6.
Sunder Rao P S S, Richard J. An Introduction to Biostatistics, A manual for students in health sciences, New Delhi: Prentice hall of India. 4th edition. 2006; 86-160.
7.
Elenbaas, RM, Elenbaas, JK, Cuddy, PG. Evaluating the medical literature, part II: Statistical analysis. Ann Emerg Med. 1983; 12(10):610-20. [crossref] [PubMed]
8.
Morgan M. The rational use of intrathecal and extradural opioids. Br J Anaesth. 1989; 63(2): 165-88. [crossref] [PubMed]
9.
Chawla R, Arora MK, Saxena R, Gode GR. Efficiency and dose-response of intrathecal pentazocine for postoperative pain relief.Indian J Med Res. 1989:220-223.
10.
Manjula R, Chaithra G, Amit G, Upakara SR, Aditi VP. Comparitive study of bupivacaine with nalbuphine and bupivacaine alone for post-operative analgesia in subarachniod block for lower limb surgeries-prospective randomised study. J Anest & Inten Care Med. 2017; 2(2): 555581. DOI: 10.19080/ JAICM.2017.01.555581 [crossref]
11.
Mark W, Marchionne AM, Anderson TM. Use of the mixed agonist-antagonist Nalbuphine in opioid-based analgesia. Acute Pain. 2004; (6): 29-39. [crossref]
12.
Rawal N, Neutinen L, Raj P, Levering S. Clinical application of subarachnoid and intrathecal opioids for pain management. International Anesthesia Clinics.1986; 24(2): 43-57. [crossref] [PubMed]
13.
Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal Nalbuphine, compared with intrathecal morphine, after cesarean delivery: An evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000;91(3):601-05. [crossref] [PubMed]
14.
Gomaa HM, Mohamed NN, Zoheir HA, Mohammed Saeid Ali. A comparison between postoperative analgesia after intrathecal Nalbuphine with bupivacaine and intrathecal fentanyl with bupivacaine after cesarean section. Egypt J Anaesth. 2014;30(4):405-10. [crossref]
15.
Gupta K, Rastogi B, Gupta PK, Singh I,Bansal M, Tyagi V. Intrathecal nalbuphine versus intrathecal fentanyl as adjuvant to 0.5% hyperbaric bupivacaine for orthopedic surgery of lower limbs under subarachnoid block: A comparative evaluation. Indian J Pain. 2016;30(2):90-95. [crossref]
16.
Bindra TK, Kumar P, Jindal G. Postoperative analgesia with intrathecal nalbuphine versus intrathecal fentanyl in cesarean section: A double-blind, randomized comparative study. Anesth Essays Res. 2018;12(2):561-65. [crossref] [PubMed]
17.
Gurunath BB, Madhusudhana R. Postoperative analgesic efficacy of intrathecal fentanyl compared to nalbuphine with bupivacaine in spinal anesthesia for lower abdominal surgeries. Anesth Essays Res. 2018;12(2):535-38. [crossref] [PubMed]
18.
Ahluwalia P, Ahluwalia A, Varshney R, Thakur S, Bhandari S. A prospective randomized double-blind study to evaluate the effects of intrathecal nalbuphine in patients of lower abdominal surgeries under spinal anaesthesia. Int J Sci Stud. 2015;3(3):19-23.
19.
Tiwari AK, Tomar GS, Agrawal J. Intrathecal bupivacaine compared with a combination of nalbuphine and bupivacaine for subarachnoid block: A randomized prospective, double-blind clinical study. Am J Ther. 2013;20(6):592-95. [crossref] [PubMed]
20.
Mostafa MG, Mohamad MF, Farrag WS. Which has a greater analgesic effect: Intrathecal nalbuphine or intrathecal tramadol? J Am Sci. 2011;7:480-84.
21.
Naaz S, Shukla U, Srivastava S,Ozhair E, Asghar A. A comparative study of analgesic effect of intrathecal Nalbuphine and Fentanyl as an adjuvant in lower limb orthopedic surgery. J Clin Diagn Res. 2017;11(7): UC25-UC28. [crossref] [PubMed]
22.
Singh N, Kumar S, Tyagi RK. A comparative clinical study of intrathecal Nalbuphine versus intrathecal Fentanyl added to 0.5% hyperbaric bupivacaine for perioperative anesthesia and analgesia in lower abdominal surgeries. IOSR J Dent Med Sci. 2017;16(3):33-40. [crossref]

DOI and Others

DOI: 10.7860/JCDR/2023/60810.17365

Date of Submission: Oct 14, 2022
Date of Peer Review: Nov 17, 2022
Date of Acceptance: Dec 06, 2022
Date of Publishing: Jan 01, 2023

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Oct 15, 2022
• Manual Googling: Nov 22, 2022
• iThenticate Software: Dec 02, 2022 (12%)

ETYMOLOGY: Author Origin

JCDR is now Monthly and more widely Indexed .
  • Emerging Sources Citation Index (Web of Science, thomsonreuters)
  • Index Copernicus ICV 2017: 134.54
  • Academic Search Complete Database
  • Directory of Open Access Journals (DOAJ)
  • Embase
  • EBSCOhost
  • Google Scholar
  • HINARI Access to Research in Health Programme
  • Indian Science Abstracts (ISA)
  • Journal seek Database
  • Google
  • Popline (reproductive health literature)
  • www.omnimedicalsearch.com