RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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.

Quick Facts

Study Start:2025-03-07
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06536517

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals with a uterus
  2. * Age 18 years old and above
  3. * Undergoing minimally invasive (laparoscopic or robotic) hysterectomy with ovarian preservation
  4. * Benign indications for hysterectomy
  5. * Agreeing to participate
  1. * Chronic pain syndromes patients including fibromyalgia
  2. * Patients currently on long-term (i.e. for more than three months) opioid use
  3. * Patients currently on agonist-antagonist medications (e.g. buprenorphine)
  4. * Patients taking a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor
  5. * Conversion to laparotomy
  6. * Allergy or other contraindication to the prescribed medications such as methadone, fentanyl, acetaminophen or oxycodone
  7. * Severe Obstructive Sleep Apnea (OSA)
  8. * Pregnant/breastfeeding patients

Contacts and Locations

Study Contact

Mostafa Borahay, MD, MBA, PhD
CONTACT
410-550-0337
mboraha1@jhmi.edu

Principal Investigator

Mostafa Borahay, MD, MBA, PhD
PRINCIPAL_INVESTIGATOR
Study Principal Investigator

Study Locations (Sites)

The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Mostafa Borahay, MD, MBA, PhD, PRINCIPAL_INVESTIGATOR, Study Principal Investigator

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-07
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-03-07
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • hysterectomy
  • methadone
  • opioids

Additional Relevant MeSH Terms

  • Fibroid Uterus