Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy

Study Overview
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Brief Summary
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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
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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

Official Title
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Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

Conditions
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Hemorrhoids

Intervention / Treatment
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* Drug: Metronidazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemorrhoidal disease grade III and IV Informed consent Exclusion Criteria: Pregnancy Lactation Other anorectal disease Previous anorectal hypersensibility to metronidazole

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metronidazole<br>22 patients received oral metronidazole 500mg 3 times for day for 7 days | Drug: Metronidazole<br>* 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<br>* Other names: Flagyl;|
| Placebo Comparator: Placebo<br>22 patients received oral placebo 500mg 3 times for day for 7 days | Drug: Placebo<br>* 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.<br>* Other names: Homologated Placebo;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoidectomy, Postoperative pain, Metronidazole