Prospective assessment of postoperative pain after craniotomy.
Christine Mordhorst, Björn Latz, Thomas Kerz...
https://pubmed.ncbi.nlm.nih.gov/20479664/Actively Recruiting
Led by University of Virginia · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
N/A
Total Duration
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 mgkg 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
Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery
J
Jennifer Phillips, RN
L
Lauren Dunn, M.D.
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University of Virginia
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | IV Methadone (Investigational Arm) | IV Remifentanil (Active Comparator) |
|---|---|---|
| What it is | An opioid analgesic administered intravenously during brain surgery. Methadone has a long half-life and is being evaluated as an alternative for intraoperative and postoperative pain control. | A short-acting intravenous opioid routinely used perioperatively in neurosurgery. Serves as an active comparator in the trial and reflects current practice for postoperative pain management. |
| Role in trial | Tested as the investigational analgesic to evaluate effects on pain and quality of recovery following craniotomy. | Serves as the current standard opioid comparator to assess differences in recovery and pain outcomes. |
| Primary use | Methadone is being used to manage perioperative pain and improve postoperative recovery, particularly after brain surgery. | Remifentanil is administered for rapid-onset pain control during and after craniotomy procedures. |
| How it is given or performed | Methadone is given intravenously during the surgical procedure, with dosing based on trial protocol and clinical needs. | Remifentanil is administered intravenously during surgery following neurosurgical anesthesia standards. |
| Evidence status | Methadone is supported by observational and retrospective studies for perioperative pain control in intracranial surgery, but randomized evidence is not yet established for craniotomy recovery outcomes. | Remifentanil is considered a standard opioid for intraoperative and postoperative pain in neurosurgery, with systematic review evidence supporting its use after craniotomy. |
| Important limitations | Methadone's longer half-life may increase risk if not carefully dosed, and there is less randomized evidence on its effects in craniotomy compared to established agents. Dose titration during surgery requires expertise. | Remifentanil's ultra-short duration requires precise infusion control to avoid breakthrough pain postoperatively, and rapid discontinuation may lead to rebound pain. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Lead Sponsor