Effectiveness of Diclofenac Plus Paracetamol for Postoperative Pain Control after Caesarean Delivery: A Randomised Controlled Trial QC01-QC03
Dr. Siriluk Norsuwan,
33, Udonthani Hospital, Muang District, Udonthani Province-41000, Udonthani, Thailand.
Introduction: Caesarean delivery is one of the commonest operations. Postoperative pain control is important for a good pregnancy experience. Although, diclofenac and paracetamol are commonly used; data about their effectiveness by the oral route in combination for pain control in the first 24-hours is limited.
Aim: To compare the effectiveness of diclofenac plus paracetamol with placebo in pain control after caesarean delivery.
Materials and Methods: A double-blind, randomised, placebo-controlled trial was conducted on term singleton 100 pregnant women who underwent caesarean sections under spinal anaesthesia using 0.5% bupivacaine plus morphine. The participants randomly received oral diclofenac 50 mg plus paracetamol 500 mg or placebo at 12-hours postoperative then every eight hours. Both groups received the same regimen of intravenous opioid by Patient Controlled Anaesthesia (PCA). The primary outcome was the comparison of pain score measured by numerical rating scale at 12, 20 and 24-hours postoperative. Secondary, outcomes were the amount of opioid use and adverse effects in both groups. The mean pain scores of both groups and all continuous variables were compared using an unpaired t-test. Chi-square and Fisher-exact tests were used for comparison of all categorical variables.
Results: A total of 100 participants were randomly placed, 50 in intervention group and 50 in the control group. The mean pain scores at 20 and 24-hours postoperative were 2.10±1.39 and 1.66±1.33 in the intervention group compared with 2.86±1.60 and 2.92±1.55 in the placebo group. The mean difference was 0.76 at 20 hours (95% CI 0.17 to 1.36, p-value=0.01) and was 1.26 at 24-hours (95% CI 0.69 to 1.83, p-value<0.01). The amount of opioid used was 1.46±2.81 mg in the intervention group and 3.34±4.53 mg in the placebo group (p-value<0.01). The adverse effects, such as nausea, vomiting, were decreased in the intervention group. There was no severe postoperative complication in either group.
Conclusion: The addition of diclofenac 50 mg plus paracetamol 500 mg orally provided better pain control with less opioid used in 24-hours after a caesarean delivery compared with intravenous opioid PCA only.