Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

Hemorrhoids Clinical Trial

Official title:

Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328144
• Other study ID #: R-2013-1301-71
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2014
• Last updated: December 26, 2014
• Start date: July 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hemorrhoidal disease grade III and IV

• Informed consent

Exclusion Criteria:

• Pregnancy

• Lactation

• Other anorectal disease

• Previous anorectal

• hypersensibility to metronidazole

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

Intervention

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
• 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.

Locations

Country	Name	City	State
Mexico	Western Medical Center, Mexican Institute of Social Security	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Satisfaction	Asking how they felt in last 14 days and what was their perception of the surgery	14 day	Yes