Status:
RECRUITING
The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
Lead Sponsor:
Johns Hopkins University
Conditions:
Fibroid Uterus
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 med...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06536517
Start Date
March 7 2025
End Date
December 1 2026
Last Update
December 12 2025
Active Locations (2)
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1
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287