Methadone for Uterine Fibroids

Recruiting at 1 trial location

Overseen by Mostafa Borahay, MD, MBA, PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Johns Hopkins University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Currently, there is a nationwide epidemic of opioid abuse and overdose deaths. One source of excess opioids is overprescribing in the postoperative period. This study aims to find the optimal pain medication plan during and after laparoscopic hysterectomy to eliminate long-term opioid use. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of Methadone, a longer opioid analgesics, intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries. The investigators hypothesize that this could minimize the need for additional post-operative and outpatient opioid prescriptions and decrease the adverse effects that are associated with the consumption, including new opioid abuse. Intervention group will receive methadone intraoperatively while the other group would receive short-acting opioids (standard).

Research Team

Mostafa Borahay, MD, MBA, PhD

Principal Investigator

Study Principal Investigator

Eligibility Criteria

This trial is for individuals with a uterus, aged 18 or older, who are undergoing minimally invasive hysterectomy with ovarian preservation for benign reasons and agree to participate. It excludes those not meeting these criteria.

Inclusion Criteria

Agreeing to participate

I have a uterus.

I am having a hysterectomy for non-cancerous reasons.

Exclusion Criteria

Pregnant/breastfeeding patients

I have been using opioids for more than three months.

I am currently taking medication that includes buprenorphine.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time intra-operative dose of Methadone or standard short-acting opioids during laparoscopic or robotic hysterectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, mobility, satisfaction of analgesia, and total post-operative opioid requirements

1 week

2 visits (in-person)

Treatment Details

Interventions

• Methadone (Opioid)

Trial Overview The study tests if one-time intraoperative methadone can reduce the need for post-surgery opioids in patients having laparoscopic hysterectomies. One group receives methadone; another gets short-acting opioids (standard care).

Participant Groups

Group I: Short-Acting Opioid Experimental Treatment 1 Intervention

Standard intra-operative IV shorter acting opioids

Group II: Methadone Experimental Treatment 1 Intervention

Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+