Actively Recruiting
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
Led by Johns Hopkins University · Updated on 2026-01-12
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the best pain medication plan during and after laparoscopic hysterectomy to reduce long-term opioid use. The trial focuses on comparing intraoperative single-dose methadone, a longer-acting opioid, with standard short-acting opioids to address the problem of opioid overprescribing after surgery. The goal is to find a safer, more effective way to manage postoperative pain and reduce the risk of opioid abuse. The study involves two groups: one receives a single intraoperative dose of intravenous methadone based on ideal body weight, while the other group receives the usual short-acting opioids during surgery. Both groups undergo minimally invasive hysterectomy, either laparoscopic or robotic, with ovarian preservation. Researchers will monitor participants during the postoperative period to evaluate pain control and opioid use. Participants will be assessed for total postoperative opioid requirements over one week, along with mobility, satisfaction with pain relief, and any unplanned healthcare visits related to pain during the first week after surgery. The study includes follow-ups on postoperative days 1 and 7 to evaluate pain management and patient satisfaction. The trial aims to reduce additional opioid prescriptions and improve recovery after hysterectomy.
CONDITIONS
Brief Title
The Effects of One-time Intraoperative Methadone During Laparoscopic Hysterectomy in Reducing Opioid Prescription.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Chronic pain syndromes including fibromyalgia
- Current long-term opioid use for more than three months
- Current use of agonist-antagonist medications like buprenorphine
- Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors
- Conversion to laparotomy during surgery
- Allergy or contraindication to methadone, fentanyl, acetaminophen, or oxycodone
- Severe obstructive sleep apnea
- Pregnant or breastfeeding patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure day
Participants receive a one-time intra-operative dose of methadone or a shorter-acting opioid during laparoscopic or robotic hysterectomy to manage postoperative pain.
1 intra-operative visit
Duration - 1 week
Participants are monitored for pain control, opioid use, mobility, and satisfaction with analgesia following surgery.
2 visits (Post-operative day 1 and day 7)
Trial Site Locations
Total: 2 locations
1
The Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
2
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
M
Mostafa Borahay, MD, MBA, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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