Randomised Controlled Trial to Compare the Efficacy of Epidural Analgesia versus Intravenous Analgesia during Thoracotomy for Repair of Oesophaeal Atresia UC01-UC05
Dr. Prabudh Goel,
Assistant Professor, Department of Paediatric Surgery, All India Institute of Medical Sciences, New Delhi-110029, India.
Introduction: The repair of oesophageal atresia by thoracotomy (or thoracoscopy) is one of the most common neonatal surgical emergencies. Peri-operative pain management in these patients is challenging due to fear of respiratory depression, post-opioid administration. The morbidity of inadequately treated pain is significant and may result in physiological instability, altered mental development and inappropriate stress response. Efficacy of use of fentanyl by the epidural route has been compared with intravenous routes often; no clear-cut consensus exists in literature. However, it has been suggested that epidural fentanyl reduces the needs for intraoperative analgesics, improves the quality of post-operative analgesia and shortens the recovery time. However, the same phenomenon has not been studied in neonates with oesophageal atresia undergoing primary repair by the thoracotomy route.
Aim: To compare the analgesic efficacy of fentanyl via epidural vs. intra-venous routes of administration during thoracotomy for primary repair of oesophageal atresia in neonates.
Materials and Methods: This was a randomised controlled trial for a span of over two years, on neonates (n=60) undergoing thoracotomy under general anaesthesia, for primary repair of oesophageal atresia. The participants were randomised into two groups to receive thoracic epidural analgesia with fentanyl and bupivacaine (Group A, n=30) and intravenous fentanyl (Group B, n=30) respectively. The monitoring and pain assessment was done in first 24 hours, adequacy of respiration was assessed by respiratory rate and oxygen saturation. Data were represented as Mean (Range±SD). Independent sample t-test and Mann Whitney U test were used to compare the heart rate and total fentanyl consumption respectively between the two groups.
Results: Patients in Group A were hemodynamically more stable (post-incision heart rate (mean±SD) was 179.4±10.9 beats per minute in Group A vis-à-vis 186±9 beats per minute in Group B, p-value=0.01) and required less analgesia (need for intraoperative fentanyl boluses: n=2 of 30 in Group A vis-à-vis 9 of 30 in Group B, p-value=0.02); total fentanyl consumption: median (IQR) 1.2 (0-2.5) mcg in Group A vis-à-vis 7.75 (6-12) mcg in Group B; p<0.0001). Extubation after surgery in operating room was more in Group A (18 of 30 vs. none in Group B, p-value <0.0001) and ventilatory requirement after six hours of surgery was more in Group B (11 of 30 vs. 2 of 30 in Group A; risk ratio (95% CI): 0.26 (0.07-0.94), p=0.005). Pain scores at the time of extubation were significantly higher in Group B (p<0.001).
Conclusion: Use of epidural fentanyl and bupivacaine has been found to be safe and superior to intravenous fentanyl in this study with a potential to offer an awake and comfortable patient at the end of surgery. However, the technique of insertion of epidural catheter neonates are demanding and require expertise with caution.