Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
NCT06810336

Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery

Led by University of Virginia · Updated on 2026-05-04

40

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality. 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 that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively. In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery. IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery. The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.

CONDITIONS

Official Title

Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult Patients between ages 18 and 65 years old.
  • Undergoing supratentorial intracranial surgery
  • American Society of Anesthesiologists (ASA) physiological status I-III
  • Body Mass Index (BMI) between 18.5 and 45
  • Ability to understand and read English
Not Eligible

You will not qualify if you...

  • Unable or unwilling to sign a consent
  • Anticipated discharge within 24 hours after surgery
  • Requirement for emergent surgery
  • Preoperative usage of methadone or allergy to it
  • Chronic pain requiring daily opioid use at the time of surgery, with oral morphine milligram equivalents (MME) greater than 60 or use of long-acting opioids
  • Active or prior substance use disorder with ongoing treatment using methadone, buprenorphine, or naltrexone
  • Preoperative chronic renal insufficiency or failure (serum creatinine over 2 mg/dl)
  • Pregnancy
  • Significant liver disease such as cirrhosis or hepatic failure
  • QTc greater than 450 on preoperative electrocardiogram
  • Pulmonary disease requiring home oxygen therapy
  • Inability to speak or read the English language

AI-Screening

AI-Powered 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

J

Jennifer Phillips, RN

CONTACT

L

Lauren Dunn, 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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