Using methadone during laparoscopic hysterectomy to reduce opioid prescriptions
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.
This study is trying to see if giving methadone during laparoscopic hysterectomy can help manage pain better and reduce the need for regular opioid painkillers after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06536517 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of administering a single dose of methadone during laparoscopic hysterectomy to manage postoperative pain and reduce the need for opioid prescriptions. The hypothesis is that methadone, with its longer-lasting analgesic properties, can minimize the reliance on short-acting opioids typically prescribed after surgery. By comparing outcomes between patients receiving methadone and those receiving standard short-acting opioids, the study aims to evaluate pain control, opioid consumption, and potential side effects. This approach seeks to address the growing concern of opioid overprescription and abuse in the postoperative setting.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older undergoing minimally invasive hysterectomy for benign conditions.
Not a fit: Patients with chronic pain syndromes, long-term opioid use, or certain contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for opioid prescriptions after surgery, thereby lowering the risk of opioid abuse and its associated complications.
How similar studies have performed: While the use of methadone for pain management in other surgical contexts has shown promise, its application in gynecological surgeries like hysterectomy is relatively novel and not extensively studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland and 1 other locations
- The Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
- The Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Mostafa Borahay, MD, MBA, PhD — Study Principal Investigator
- Study coordinator: Mostafa Borahay, MD, MBA, PhD
- Email: mboraha1@jhmi.edu
- Phone: 410-550-0337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.