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Pain Control After Major Abdominal Surgery

This study is comparing two pain medications, intravenous (IV) methadone and intrathecal (IT) morphine, for controlling pain after major abdominal surgery. Researchers want to see which medication leads to better recovery and less need for other pain medicines. You may be able to join if you are an adult between 18 and 75 years old, are having major abdominal surgery, and meet other health criteria. The study will measure your quality of recovery and how much pain medication you use over several weeks. This study plans to enroll 40 participants.

Study design
This interventional study plans to enroll 40 participants to compare two different pain medications.
What's involved
You would need to be willing and able to attend scheduled visits and follow study procedures. The study will measure outcomes at 24 hours, 48 hours, 72 hours, 42 days, and 92 days after surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 92 days after surgery to assess recovery and pain medication use.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06387303

Pain Control and Quality of Recovery After Intravenous Methadone Versus Intrathecal Morphine in Major Abdominal Surgery

UNKNOWN
EARLY_PHASE1Ages 18–75InterventionalHealth services
University of Virginia
~40 participants
Updated 2025-08-11 on ClinicalTrials.gov
What's tested:MethadoneMorphine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quality of Recovery 15 score
Measured over 24 hours, 48 hours, 72 hours, 42 days, 92 days
+3 more outcomes measured

Conditions

Pain, Postoperative

Explore related trials

Post-Operative Pain

Where it's being run

1 sites across 1 states
Virginia1

Who to contact

Keita Ikeda, PH.D.
[email protected]
9195931174
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Quality of Recovery 15 score24 hours, 48 hours, 72 hours, 42 days, 92 days

    The Quality of Recovery-15 (QoR-15) scale is a patient-reported outcome measurement of the quality of recovery after surgery and anesthesia. The scale ranges from 0 to 150, with a higher score indicating a better quality of recovery. A score of 0 indicates extremely poor quality of recovery, while a score of 150 indicates excellent quality of recovery. The QoR-15 score can be classified into four severity classes: excellent, good, moderate, and poor recovery.

  • Overall Benefits of Analgesic Score24 hours, 48 hours, 72 hours, 42 days, 92 days

    The overall benefit of analgesic score (OBAS) is a daily survey that assesses a patient's satisfaction with analgesia, pain intensity, and adverse effects. To compute score, add all scores in items 1-7. Range: \[0 - 28\]. A low score indicates high benefit 1. Rate your current pain at rest on a scale between 0=minimal pain and 4=maximum imaginable pain 2. Grade any distress and bother from vomiting in the past 24 hours (0=not at all to 4=very much) 3. Grade any distress and bother from itching in the past 24 hours (0=not at all to 4=very much) 4. Grade any distress and bother from sweating in the past 24 hours (0=not at all to 4=very much) 5. Grade any distress and bother from freezing in the past 24 hours (0=not at all to 4=very much) 6. Grade any distress and bother from dizziness in the past 24 hours (0=not at all to 4=very much) 7. How satisfied are you with your pain treatment during the past 24 hours (0=not at all to 4= very much)

  • morphine milligram equivalent24 hours, 48 hours, 72 hours

    morphine milligram equivalent is a measurement of a given analgesic effect standardized to a milligram of morphine. In other words agent X has the same effect as Y milligrams of morphine.

  • Numeric Rating Scale pain scores (NRS)24 hours, 48 hours, 72 hours

    The numeric rating scale (NRS) is a pain screening tool commonly used to assess pain severity at a given moment in time. It uses a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable."