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NCT Number: NCT02328144

Effectiveness of Metronidazole 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

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Key information

Conditions

Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Western Medical Center, Mexican Institute of Social Security

Guadalajara, Jalisco, 44340, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemorrhoidal disease grade III and IV
  • Informed consent

Exclusion criteria

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

Treatment and study plan

Metronidazole

Drug

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

Drug

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

Primary outcomes

  1. Pain evolution, hours and days after surgery

    Time frame: 6 and 12 hours, 1, 4, 7 and 14 days

    Pain was assessed with the visual analogue scale questionnaire

Secondary outcomes

  1. Interleukin

    Time frame: after surgery and 12 hours

    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

  2. Analgesics

    Time frame: 6 and 12 hours, 1, 4, 7 and 14 days

    Using a questionnaire if they used analgesics, which one, dose of it and how many days

  3. Surgery complications

    Time frame: 6 and 12 hours, 1, 4, 7 and 14 days

    Asking directly to participants if they presented bleeding, urinary retention or another complication. Investigators measured how many participants presented complications

  4. Return to normal activities

    Time frame: 1, 4, 7 and 14 days

    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

  5. Satisfaction

    Time frame: 14 day

    Asking how they felt in last 14 days and what was their perception of the surgery

Sponsors and collaborators

Lead sponsor

Instituto Mexicano del Seguro Social

Other Gov

Registry information

Official study title

Effectiveness of Metronidazole Versus Homologated Placebo in Pain Control Posthemorrhoidectomy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 31, 2014
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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