Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT06387303

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

Led by University of Virginia · Updated on 2025-08-11

40

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Moderate to severe postoperative pain is relatively common after major abdominal surgery. It is associated with less than optimal surgical experience, poor quality of recovery, and the development of persistent postsurgical pain. Opioids remain a significant component of postoperative pain management. Side effects of opioids used for the treatment of postoperative pain include constipation, pruritus, nausea, and vomiting. Enhanced recovery after surgery (ERAS) protocols involve the utilization of multimodal analgesia. Analgesic techniques used include epidural analgesia, nerve blocks, and Intrathecal (IT) administration of morph ne. IT morphine reduces the postoperative opioid requirement for 18-24 hours after major abdominal surgery and reduces hospital length of stay (LOS) compared with epidural analgesia. A significant number of patients who receive IT morphine still experience moderate to severe postoperative p in. Additionally, many patients refuse the invasive procedure or cannot receive IT morphine due to procedure contraindications, thrombocytopenia, and/or coagulopathy. Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients who underwent orthopedic, abdominal, complex spine, and cardiac surg ry. Similar findings have been shown in obstetric patients who underwent cesarean delivery under general anesthesia as well as patients who underwent gynecologic surgery. IV methadone has, however, never been compared with IT morphine as a postoperative analgesic. The hypothesis is that intravenous (IV) methadone is non-inferior to IT morphine in patients who undergo major abdominal surg ry. It offers the advantage of being a noninvasive analgesic modality that may contribute to decreasing opioid consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving the quality of recovery after surgery.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Unable or unwilling to sign consent
  • Undergoing ambulatory surgery or expected discharge within 24 hours after surgery
  • Chronic pain requiring daily opioid use at surgery time, opioid tolerant as defined by MME >60, or using long-acting opioids such as fentanyl patch or oxycontin
  • Pregnant women
  • Requiring emergency surgery
  • Contraindications to neuraxial anesthesia including coagulopathy, localized infection at injection site, or specific pre-existing spinal pathology (active radiculopathy, severe central canal stenosis, acute lumbar fracture)
  • QT interval (QTc) >450 on recent preoperative electrocardiogram
  • Prior spinal fusion
  • Active or prior substance use disorder currently treated with opioid use disorder medications including methadone (once daily), buprenorphine, or naltrexone

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22908-0710

Actively Recruiting

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Research Team

K

Keita Ikeda, PH.D.

CONTACT

P

Priyanka Singla, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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