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Opioid

Methadone vs Morphine for Postoperative Pain

Phase < 1
Recruiting
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Undergoing laparotomy with midline incision
Must not have
Not able or unwilling to sign consent
Patients with chronic pain, requiring daily opioid use at the time of surgery, MME >60 as FDA defines opioid tolerant as 60 MME, long-acting forms of opioids such as fentanyl patch, oxycontin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours, 48 hours, 72 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial compares the effectiveness of intravenous (IV) methadone to Intrathecal (IT) morphine for managing postoperative pain in patients undergoing major abdominal surgery. The goal is to see

Who is the study for?
This trial is for patients undergoing major abdominal surgery who need pain management post-surgery. It's not suitable for those with blood clotting issues or low platelet counts, as they can't receive intrathecal morphine.
What is being tested?
The study compares two pain control methods after abdominal surgery: IV methadone and IT morphine. The goal is to see if methadone, a noninvasive option, controls pain just as well without the side effects of morphine.
What are the potential side effects?
Possible side effects include constipation, itching, nausea, and vomiting. Methadone may also reduce these opioid-related side effects compared to IT morphine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am an adult with a health status rated between 1 to 3 by the ASA.
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I am scheduled for surgery that involves a cut down the middle of my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable or unwilling to sign the consent form.
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I use daily opioids for chronic pain, with a dose over 60 MME.
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I have had a spinal fusion surgery.
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I am currently being treated for a Substance Use Disorder with medications like methadone, buprenorphine, or naltrexone.
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I need urgent surgery.
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I am having surgery that won't require me to stay in the hospital for more than a day.
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I do not have conditions that prevent spinal anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours, 48 hours, 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours, 48 hours, 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall Benefits of Analgesic Score
Quality of Recovery 15 score
Verbal Rating Scale (VRS) pain scores
+1 more
Secondary study objectives
McGill Pain questionnaire score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous MethadoneExperimental Treatment1 Intervention
0.2 mg / kg Intravenous delivery prior to incision
Group II: Intrathecal MorphineActive Control1 Intervention
250 mcg Intrathecal Injection prior to incision
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methadone
2002
Completed Phase 4
~4460

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,662 Total Patients Enrolled
2 Trials studying Postoperative Pain
187 Patients Enrolled for Postoperative Pain
~27 spots leftby May 2026
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