BACKGROUND: Anal sphincter spasm may aggravate pain after haemorrhoidectomy. The aims of this study were to investigate whether a trimebutine suppository (Proctolog) reduced anal resting pressure and, subsequently, to test its efficacy in relieving pain after haemorrhoidectomy. METHODS: Ten patients underwent anal manometry before and 4 h after Proctolog application. A controlled randomized trial was then conducted on 160 consecutive patients. A standard haemorrhoidectomy was performed. Eighty patients were then randomized to receive an application of Proctolog immediately after the procedure (group 1). The remaining 80 did not receive a suppository (controls, group 2). An independent, blinded observer determined the pain scores. RESULTS: Proctolog resulted in a mean 35 per cent reduction in resting anal pressure (P < 0.001). However, there were no differences in the pain score at 4 h after haemorrhoidectomy, maximum pain during the first 24 h, maximum pain during the second postoperative day, ketoprofen requirement or need for intramuscular pethidine injections between groups 1 and 2. CONCLUSION: Although Proctolog reduced mean resting anal pressure at 4 h after application, this did not affect pain after haemorrhoidectomy.
RCT Entities:
BACKGROUND:Anal sphincter spasm may aggravate pain after haemorrhoidectomy. The aims of this study were to investigate whether a trimebutine suppository (Proctolog) reduced anal resting pressure and, subsequently, to test its efficacy in relieving pain after haemorrhoidectomy. METHODS: Ten patients underwent anal manometry before and 4 h after Proctolog application. A controlled randomized trial was then conducted on 160 consecutive patients. A standard haemorrhoidectomy was performed. Eighty patients were then randomized to receive an application of Proctolog immediately after the procedure (group 1). The remaining 80 did not receive a suppository (controls, group 2). An independent, blinded observer determined the pain scores. RESULTS:Proctolog resulted in a mean 35 per cent reduction in resting anal pressure (P < 0.001). However, there were no differences in the pain score at 4 h after haemorrhoidectomy, maximum pain during the first 24 h, maximum pain during the second postoperative day, ketoprofen requirement or need for intramuscular pethidine injections between groups 1 and 2. CONCLUSION: Although Proctolog reduced mean resting anal pressure at 4 h after application, this did not affect pain after haemorrhoidectomy.