Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

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

Study Overview

• Status: Completed
• Conditions: Hemorrhoids
• Intervention / Treatment: Drug: Metronidazole; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Western Medical Center, Mexican Institute of Social Security

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hemorrhoidal disease grade III and IV
• Informed consent

Exclusion Criteria:

• Pregnancy
• Lactation
• Other anorectal disease
• Previous anorectal
• hypersensibility to metronidazole

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metronidazole; 22 patients received oral metronidazole 500mg 3 times for day for 7 days	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; Other Names: Flagyl
Placebo Comparator: Placebo; 22 patients received oral placebo 500mg 3 times for day for 7 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.; Other Names: Homologated Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evolution, hours and days after surgery	Pain was assessed with the visual analogue scale questionnaire	6 and 12 hours, 1, 4, 7 and 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin	In a blood sample, right after surgery and 12 hours later, interleukin 6 and 10 were measured by ELISA, observing if they presented alterations with the intervention, between 2 groups and between the hours the investigators took the blood sample	after surgery and 12 hours
Analgesics	Using a questionnaire if they used analgesics, which one, dose of it and how many days	6 and 12 hours, 1, 4, 7 and 14 days
Surgery complications	Asking directly to participants if they presented bleeding, urinary retention or another complication. Investigators measured how many participants presented complications	6 and 12 hours, 1, 4, 7 and 14 days
Return to normal activities	Asking to participans when they return to normal activities (to walk normally, to cook, to bath, to wear, to work) How many days were needed to recover their normal activities	1, 4, 7 and 14 days
Satisfaction	Asking how they felt in last 14 days and what was their perception of the surgery	14 day

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: Clotilde Fuentes-Orozco, PhD, Instituto Mexicano del Seguro Social

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 26, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 26, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Metronidazole; Postoperative pain; Hemorrhoidectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: R-2013-1301-71