RecruitingPhase 2NCT06536517

The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.

A Randomized Controlled Trial to Study the Effects of One-time Intra-operative Dosing of Methadone During Laparoscopic or Robotic Hysterectomy in Reducing Opioid Prescription.


Sponsor

Johns Hopkins University

Enrollment

100 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether giving a single dose of methadone (a long-acting pain medication) during a minimally invasive hysterectomy can reduce the need for opioid pain pills after patients go home. The goal is to minimize post-operative opioid prescriptions and reduce addiction risk. **You may be eligible if...** - You are 18 or older and have a uterus - You are having a laparoscopic or robotic hysterectomy for a non-cancer reason - Your ovaries will be preserved during surgery **You may NOT be eligible if...** - You have chronic pain conditions such as fibromyalgia - You are currently using opioids regularly (more than 3 months) - You take buprenorphine or similar medications - You take SSRIs (certain antidepressants) or MAOIs - You are pregnant or breastfeeding - You have severe sleep apnea Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethadone

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


Locations(2)

The Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

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NCT06536517


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