Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

Hemorrhoids Clinical Trial

Official title: Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

Status Completed

Clinical Trial Summary

Hemorrhoidal disease occurs in 50% of people over 40 years old and is the most common cause of anorectal surgery. One of the complications of hemorrhoidectomy is pain, which is a difficult symptom to appreciate and assess, by its frequent and large variations in sensitivity in each patient. Many studies have been done to reduce patient postoperative pain, but there is no ideal method. The application of both oral and topical metronidazole has shown to decrease pain following hemorrhoidectomy, but its use is not standardized.

The investigators evaluated the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy

Clinical Trial Description

Objective: Evaluate the effect of oral administration of metronidazole versus homologated placebo in pain control after hemorrhoidectomy.

Material and methods: Controlled clinical trial, composed of 44 patients in a randomized manner, realized at the Coloproctology, Western Medical Center, Mexican Institute of Social Security. Referred beneficiaries adults were included, of either sex, who merited elective hemorrhoidectomy for hemorrhoidal disease grades III-IV using Ferguson's technique. They were assigned to receive metronidazole (study group) or homologated (control group) and the randomization was conducted by sealed envelopes and subsequently. We collected demographic and clinical variables. Postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days; additional analgesic use; complications; return to normal activity and patient satisfaction; also were measured, in a blood sample after surgery and 12 hrs later, interleukin 6 and 10.

The statistical analysis was performed according to the nature of variables, for continuous data using measures of central tendency and dispersion and for the qualitative data with frequencies and percentages ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

• NCT number: NCT02328144
• Study type: Interventional
• Source: Instituto Mexicano del Seguro Social
• Status: Completed
• Phase: Phase 3
• Start date: July 2013
• Completion date: October 2014