To Evaluate The Analgesic Efficacy Of Intraperitoneal Tramadol Vs Placebo For Post Operative Pain Relief Following Laparoscopic Cholecystectomy, A Double Blind Randomized Control Trial, Hospital Based Study

Abstract

Background and objectives Postoperative pain remains one of the main cause of delay in resumption of activities after laparoscopic cholecystectomy. The study was undertaken to find the effectiveness of intraperitoneal instillation of tramadol for postoperative pain relief following laparoscopic cholecystectomy and adverse effects following laparoscopic cholecystectomy. Methodology This one year double blinded randomized controlled trial was done from January 2013 to December 2013 at KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, Belgaum. A total of 60 patients undergoing elective cholecystectomy were enrolled. The patients were divided into two groups of 30 each as Group S (Normal Saline) and Group T (Tramadol). Results Most of the patients were males (66.67% each) in both the groups and male to female ratio was 2:1 (p=1.000). The mean age in group S was 42.20 ± 13.03 compared to 39.83 ± 11.66 years (p=0.461). Comorbid conditions and clinical presentation of the study population in group S and T were comparable (p>0.050). The mean duration of surgery was 96.37 ± 21.69 minutes in group S and in group T it was 96.83 ± 17.80 minutes (p=0.928). In patients with group T, the mean pain scores at all the intervals were significantly low (p<0.050) except at 24 hours (p=0.210). The requirement of analgesia was high in group S compared to group T immediate post op, 15 minutes, 50 minutes, 8 hours and 12 hours (p<0.050). The mean requirement of analgesia immediate post op, 15 minutes, 4 hours and 8 hours was low in group T compared to group S (p<0.050). Higher patients (30%) in group T did not require analgesia at all compared to group S (p<0.001). Higher incidence of adverse effects at 4 hours interval was 43% in group S compared to 40% in group T (p>0.050). Conclusion and interpretation Overall, intraperitoneal instillation of tramadol is beneficial in terms of postoperative pain relief following laparoscopic cholecystectomy.