NCT02328144

Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Hemorrhoids

Interventions

Type	Name	Description
DRUG	Metronidazole	Patients were assigned to two groups, one of them received oral metronidazole (study group) and the other, homologated placebo (control group) after hemorrhoidectomy. Then, postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days
DRUG	Placebo	Patients were assigned to two groups, one of them received oral metronidazole (study group) and the other, homologated placebo (control group) after hemorrhoidectomy. Then, postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-08-01
• Completion: 2014-10-01
• First posted: 2014-12-31
• Last updated: 2014-12-31

Locations

1 site across 1 country: Mexico