Efficacy of Diclofenac Transdermal Patch versus Diclofenac Rectal Suppository for Management of Postoperative Pain Following Open Cholecystectomy: A Randomised Clinical Trial

Abstract

Introduction: Postoperative pain can have detrimental effects if proper analgesia is not provided. The most widely used medicines for the management of postoperative pain is Non Steroidal Anti-Inflammatory Drugs (NSAIDs), among the NSAIDs the most commonly used drug for postoperative pain is diclofenac sodium. Repeated intramuscular/intravenous (i.m/i.v.) injections of diclofenac are associated with pain and discomfort while oral use of diclofenac before and after surgery is limited and is also associated with increased risk of gastrointestinal complications like dyspepsia, peptic ulcer etc. Diclofenac Transdermal Patch (TD) and Rectal Suppository (RS) are good methods of drug delivery as they avoid first pass metabolism, gastrointestinal complications and pain associated with i.m/i.v. route. Aim: To evaluate the efficacy of the transdermal diclofenac patch versus the diclofenac RS for management of postoperative pain following open cholecystectomy. Materials and Methods: This hospital-based, randomised, prospective, interventional, open label comparative clinical trial was conducted in Department of General Surgery and Department of Pharmacology at FH Medical College and Hospital, Agra, Uttar Pradesh, India, from April 2021 to September 2021. A total of 64 patients were included in the trial and they were randomly divided into two groups using simple randomisation technique. Group A received 100 mg diclofenac TD (n=32) and group B received 100 mg diclofenac RS (n=32) just before induction of anaesthesia and repeated 12 hourly for 48 hours. Pain was assessed postoperatively at 6, 12, 24 hours, respectively using the Visual Analogue Scale (VAS) and adverse effects like gastrointestinal complications were also noted in the both groups. The Student’s t-test was applied to compare the mean values of quantitative variables while qualitative variables were analysed using Chi-square test. A p-value <0.05 was considered statistically significant. Results: Both the groups were comparable with respect to age (p-value=0.1048) and gender distribution (p-value=0.3760). VAS score at 12 hours and 24 hours postsurgery in patients of both groups showed significant decrease (p-value=0.0001), when compared with VAS score values at 6 hours postsurgery of the same group. On comparison of VAS score between the two groups at 6 hour, 12 hour and 24 hour significant decrease (p-value <0.05) in VAS score was observed with a higher decrement in group B patients i.e., those who received diclofenac rectal suppositories. In group A, seven patients needed rescue analgesia while in group B only three patients required rescue analgesia. Conclusion: Rectal diclofenac suppository had higher efficacy in comparison to transdermal diclofenac patch in management of postoperative pain.

Keywords

• new drug delivery
• non steroidal anti-inflammatory drugs
• routes
• visual analog scale