The evaluation of the efficacy of etofenamate spray in postoperative cesarean pain: Randomized, double-blind, placebo-controlled trial

Abstract

Objective: It was aimed to investigate the effect of etofenamate spray to be applied around the postoperative incision on pain control in cesarean section in this trial. Material and methods: This was a prospective, randomized, double-blind, and placebo-controlled trial. 187 patients (93 cases and 94 controls) were recruited for the study. In the trial group, we applied the etofenamate spray (Doline® 50 ml) after closing the cesarean skin incision and go on four times a day on the skin incision for 24 h. In the control group, we applied a placebo. All patients received paracetamol IV (Paracerol®) as standard analgesic doses. If analgesia was insufficient, tramadol (Contramal®) 50 mg IV doses were added and recorded. A visually analog pain scale (VAS) was performed on both groups at 6–12–18–24th hours. Independent t-tests were performed for data showing normal distributions. Results: There were no significant differences in the mean of differences VAS scores between the two groups at 6–12, and 6–18 h. However, a significant difference was obtained in the mean of differences VAS score at the 6-24th hour (p < 0.05). When the groups were compared in terms of additional paracetamol need, a significant difference was found again (p < 0.05). There was no significant difference between the groups in terms of tramadol need. Conclusion: Postoperative administration of etofenamate spray provided an analgesic effect at 24 h and additional analgesic usage decreased. Postoperative analgesia can also be used by administering NSAIDs around the cesarean section incision. In this way, the side effects of other systemic analgesics are avoided. Clinical trial id: PACTR201811864509898. Clinical trial web link: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5745.

Keywords

• Cesarean section
• Etofenamate
• NSAIDs
• Postoperative analgesia
• Visually numerical pain scale