Randomized controlled trial of trimebutine (anal sphincter relaxant) for pain after haemorrhoidectomy

Br J Surg. 1997 Mar;84(3):377-9.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Female
  • Hemorrhoids / surgery*
  • Humans
  • Male
  • Manometry
  • Pain Measurement
  • Pain, Postoperative / prevention & control*
  • Parasympatholytics / administration & dosage
  • Parasympatholytics / therapeutic use*
  • Pilot Projects
  • Suppositories
  • Trimebutine / administration & dosage
  • Trimebutine / therapeutic use*

Substances

  • Parasympatholytics
  • Suppositories
  • Trimebutine