The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery

  • STATUS
    Recruiting
  • End date
    Sep 15, 2027
  • participants needed
    90
  • sponsor
    University of Louisville
Updated on 15 March 2022
postoperative pain
endometriosis
endometriosis surgery
Accepts healthy volunteers

Summary

The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.

Description

The study is a prospective, randomized, placebo-controlled trial. Women scheduled for endometriosis surgery between 18-50 years of age will be invited to participate in the study.

Participants with surgically staged endometriosis will be randomized to the metronidazole plus routine postoperative care arm or the placebo plus routine postoperative care arm. Participants will take study or placebo drug for a total of 14 days.

Participants will complete surveys at baseline and postoperatively at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years reporting intensity of endometriosis associated pain on a visual analog scale, pregnancy outcomes, quality of life, and sexual health.

Details
Condition Endometriosis, Endometriosis-related Pain
Treatment Placebo, Metronidazole Oral
Clinical Study IdentifierNCT04554693
SponsorUniversity of Louisville
Last Modified on15 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to give informed consent
Women aged 18-50 years old
Scheduled to undergo excision of endometriosis
Able to read and write in English and or Spanish
Pain score > 2 on a 10 point visual analogue scale at baseline
Negative screening by CAGE questionnaire

Exclusion Criteria

Refusal to surgery
Contraindication to surgery
Known allergy to metronidazole
Known allergy to any component in gelatin placebo capsules
Scheduled hysterectomy
Endometriosis excision surgery within the last 3 months
Elevated serum creatinine
Abnormal liver function test greater than 2 times the normal
Current pregnancy
Breastfeeding
Use of Disulfiram within the last 2 weeks
History of Cockayne syndrome
Inability to abstain from alcohol during the use of study drug
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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