Actively Recruiting

Early Phase 1
Age: 18Years - 65Years
All Genders
ID06810336

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

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Postoperative pain is common after intracranial surgery, especially craniotomy. Patients usually receive short-acting opioids to allow early neurological exams and reduce respiratory depression risks. However, many experience moderate to severe pain within 48 hours after surgery, which can lead to complications like high blood pressure and intracranial bleeding, increasing risks of illness and death. Researchers are studying intravenous (IV) methadone, which has a long pain-relief effect and additional properties that may help reduce opioid needs and improve recovery after surgery. This study compares IV methadone with the usual IV remifentanil treatment in patients undergoing elective intracranial surgery to see if methadone is not worse than remifentanil for recovery quality. Participants are randomly assigned to receive either IV remifentanil with doses adjusted by the anesthesia team or a single dose of IV methadone (0.2 mg/kg) given before surgery starts. The trial focuses on patients having supratentorial intracranial surgery under general anesthesia. The treatments aim to manage pain during and after surgery, with methadone expected to reduce opioid use and improve pain control over the first 72 hours post-surgery. The study lasts through the immediate postoperative period, monitoring recovery and complications. During the study, participants will be assessed for quality of recovery on postoperative days 1, 2, and 3 using a questionnaire. Researchers will also measure opioid use, pain intensity scores, benefits of analgesics, complications, and hospital stay length. Pain and recovery data will be collected at specific intervals up to 72 hours after surgery. The study includes safety monitoring and aims to observe differences in recovery quality and pain control between the two treatment methods over about 3 days following surgery.

CONDITIONS

Brief 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 18 and 65 years old
  • Undergoing supratentorial intracranial surgery
  • American Society of Anesthesiologists (ASA) status I to 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 consent
  • Expected discharge within 24 hours after surgery
  • Require emergent surgery
  • Preoperative methadone use or allergy to methadone
  • Chronic pain requiring daily opioid use over 60 MME
  • Active or prior substance use disorder with current opioid treatment
  • Chronic renal insufficiency or failure (serum creatinine > 2 mg/dl)
  • Pregnancy
  • Significant liver disease such as cirrhosis or hepatic failure
  • QTc interval over 450 on preoperative electrocardiogram
  • Pulmonary disease requiring home oxygen
  • Inability to speak or read English

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single intraoperative dose

Participants receive either a single dose of intravenous methadone or titratable intravenous remifentanil during their elective intracranial surgery.

1 baseline visit (day of surgery)

Post-operative Follow-up

Duration - Up to 72 hours after surgery

Participants are monitored for postoperative pain, opioid requirements, recovery quality, and complications during the first 72 hours after surgery.

Daily visits for 3 days post-surgery

Hospital Stay Observation

Duration - 5 to 10 days

Participants remain in the hospital for routine care and monitoring until discharge, which typically ranges from 5 to 10 days after surgery.

Approximately daily assessments during hospital stay

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

L

Lauren Dunn, M.D.

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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Published Research Related To This Trial

Efficacy and safety of intraoperative intravenous methadone during general anaesthesia for caesarean delivery: a retrospective case-control study.

T Russell, C Mitchell, M J Paech...

https://pubmed.ncbi.nlm.nih.gov/23219678

Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients.

Glenn S Murphy, Joseph W Szokol, Michael J Avram...

https://pubmed.ncbi.nlm.nih.gov/25837528