Active — Not RecruitingPhase 4

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

United States90 participantsStarted 2020-10-19

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Self-reported pain persistence

Timeframe: 6 weeks postoperatively.

Trial details

NCT IDNCT04554693

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Endometriosis trials