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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Individuals with a uterus

• Age 18 years old and above

• Undergoing minimally invasive (laparoscopic or robotic) hysterectomy with ovarian preservation

• Benign indications for hysterectomy

• Agreeing to participate

Locations
United States
Maryland
The Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
The Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Mostafa Borahay, MD, MBA, PhD
mboraha1@jhmi.edu
410-550-0337
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Experimental: Methadone
Intra-operative single dose IV Methadone (0.25 mg/kg of ideal body weight)
Other: Short-Acting Opioid
Standard intra-operative IV shorter acting opioids
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov