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

NCT06536517 | Recruiting Phase 2

• 1 other identifier: IRB00459067
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Fibroid Uterus

Keywords

hysterectomy; methadone; opioids

Outcome Measures

Primary Outcomes (1)

• Total post-operative opioid requirements in oral morphine milligram equivalents (MME)

  Total post-operative opioid requirements in oral morphine milligram equivalents (MME) in first 7 post operative days.

  1 week

Secondary Outcomes (3)

• Mobility and satisfaction of analgesia

  Post operative day 1, Post operative day 7

• Number of unplanned returns to emergency room/clinic or patient initiated phone call regarding pain

  1 week

• Overall satisfaction with pain control

  1 week

Study Arms (2)

Methadone

EXPERIMENTAL

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

Drug: Methadone

Short-Acting Opioid

OTHER

Standard intra-operative IV shorter acting opioids

Drug: Methadone

Interventions

Methadone DRUG

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

Methadone; Short-Acting Opioid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Chronic pain syndromes patients including fibromyalgia
• Patients currently on long-term (i.e. for more than three months) opioid use
• Patients currently on agonist-antagonist medications (e.g. buprenorphine)
• Patients taking a selective serotonin reuptake inhibitor or monoamine oxidase inhibitor
• Conversion to laparotomy
• Allergy or other contraindication to the prescribed medications such as methadone, fentanyl, acetaminophen or oxycodone
• Severe Obstructive Sleep Apnea (OSA)
• Pregnant/breastfeeding patients

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

The Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

Methadone

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Mostafa Borahay, MD, MBA, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Borahay, MD, MBA, PhD

CONTACT

410-550-0337; mboraha1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: March 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)