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

NCT ID: NCT06536517

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-07
• Study Completion Date: 2026-12-31

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).

Detailed Description

Problem:

The relief of moderate to severe postoperative pain in surgeries including abdominal surgeries continues to pose a major therapeutic dilemma. The traditional and most common therapy is the administration of short-acting opioid analgesics, intra-operative and post-operative, at intervals every 3-4 hours. However, the use of opioids with relatively short plasma half-lives at varying intervals may lead to various fluctuating drug concentrations in plasma, and side effects including respiratory, longer hospitalizations, delayed ambulation, inadequate pain relief and potential avenues for abuse. Identifying a more efficient and safer therapy for intraoperative pain analgesia can be helpful in controlling pain requirements in the post-operative setting.

In major inpatient and ambulatory surgeries, intraoperative single-dose methadone, through its unique pharmacology, has been shown to produce better analgesia, reduce opioid use and minimize adverse side effects compared with conventional repeated dosing of short-duration opioids. Additionally, methadone is theorized to be an N-methyl-D-aspartate (NMDA) receptor noncompetitive antagonist, which may contribute to its increase in analgesic potential as compared with fentanyl analogues. Finally, it has been shown to improve ambulation in the post operative anesthesia setting and pain control in chronic pain patients. The study of intra-operative methadone has not been extensively studied for gynecology surgeries, but one study has shown the decrease of mean opioid consumption post operatively after receiving one dose of intra-operative methadone compared to shorter acting opioids in same-day laparoscopic myomectomy. Given the increasing opioid abuse and over-prescription post-operatively, an effort should be made to determine whether one time dosing of longer opioid analgesics intra-operatively is an adequate potential in treating postoperative pain after hysterectomy surgeries and could minimize the need for additional post-operative and outpatient opioid prescriptions.

This study aims at addressing the requirement for postoperative opioid prescription after intraoperative longer acting vs shorter acting opioids in laparoscopic hysterectomy.

Hypothesis:

Single dose of intra-operative methadone is an adequate potential in treating post-operative pain after laparoscopic total hysterectomy surgeries, reducing the additional need for post-operative and outpatient opioid prescriptions and decreasing the adverse effects associated with opioid consumption.

Importance of research:

Given the increasing opioid abuse and over-prescription post-operatively, an effort must be made to determine whether one time dosing of longer opioid analgesics intraoperatively in conjunction with non-opioid multimodal medications is adequate to treat postoperative pain after laparoscopic hysterectomy. Additionally, this intervention may decrease the need for additional prescriptions or unscheduled patient contacts.

Conditions

Fibroid Uterus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Methadone

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

Group Type: EXPERIMENTAL

Methadone

Intervention Type: DRUG

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

Short-Acting Opioid

Standard intra-operative IV shorter acting opioids

Group Type: OTHER

Methadone

Intervention Type: DRUG

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

Interventions

Methadone

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mostafa Borahay, MD, MBA, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

The Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mostafa Borahay, MD, MBA, PhD

Role: CONTACT

mboraha1@jhmi.edu

410-550-0337

Facility Contacts

Mostafa Borahay

Role: primary

Mostafa Borahay

Role: primary

Other Identifiers

IRB00459067

Identifier Type: -

Identifier Source: org_study_id