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

University of Louisville (UOFL)

Status and phase: Enrolling; Phase 4

Conditions: Endometriosis-related Pain; Endometriosis

Treatments: Drug: Metronidazole Oral; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04554693

200544

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Metronidazole

Experimental group

Description:

Metronidazole

Treatment:

Drug: Metronidazole Oral

Placebo

Placebo Comparator group

Description:

Halal and Kosher certified gelatin placebo capsules

Treatment:

Drug: Placebo