Comparing Methadone and Morphine for Pain Control After Abdominal Surgery
Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery
This study tests whether using methadone or morphine is better for controlling pain and helping people recover after major abdominal surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06387303 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intravenous methadone versus intrathecal morphine for managing postoperative pain in patients undergoing major abdominal surgery. The study aims to determine which method provides better pain control and quality of recovery while minimizing opioid-related side effects. Participants will be monitored for pain levels, recovery quality, and any adverse effects associated with the analgesic methods used. The trial focuses on enhancing recovery after surgery through multimodal analgesia approaches.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients with ASA physiological status I-III undergoing laparotomy with a midline incision.
Not a fit: Patients with chronic pain requiring daily opioid use or those undergoing emergent surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that enhance recovery and reduce opioid-related side effects for patients after major abdominal surgery.
How similar studies have performed: Previous studies have shown that intravenous methadone can effectively reduce postoperative pain and opioid requirements, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III * Undergoing laparotomy with midline incision * Body mass index (BMI) between 18.5 and 45 * Ability to understand and read English * Willingness and ability to comply with scheduled visits and study procedures Exclusion Criteria: * Not able or unwilling to sign consent * Patients undergoing ambulatory surgery or anticipated to be discharged sooner than 24 hours after surgery * Patients with chronic pain, requiring daily opioid use at the time of surgery, MME \>60 as the FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin. * Pregnant Women * Patients requiring emergent surgery * Contraindications to neuraxial anesthesia including: * Coagulopathy * localized infection at the site of injection * pre-existing spinal pathology, specifically defined as active radiculopathy, severe central canal stenosis in the lumbar region, or an acute fracture in the lumbar region * length of the QT interval (QTc) \>450 on the most recent preoperative electrocardiogram (EKG) * Prior spinal fusion * Active or Prior Substance Use Disorder, undergoing active treatment with Medication of Opioid Use Disorder including methadone (once daily dosing), Buprenorphine (any formulation) and Naltrexone
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Keita Ikeda, PH.D.
- Email: ki2d@uvahealth.org
- Phone: 9195931174
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.