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Postoperative Pain and Headache After Craniotomy

NCT03908944 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-06-12

No results posted yet for this study

Summary

The purpose of this study is to assess the outcomes of an anesthetic technique which is not synthetic opioid based, on postoperative pain modulation and development of post craniotomy headache against a cohort of patients where an opioid based standard anesthetic technique was used for craniotomy. The hypothesis that is tested is that the use of agents other than synthetic short acting opioids will reduce the amount of postoperative pain and the incidence of headache after surgery.

Conditions

  • Postoperative Pain

Interventions

DRUG

Methadone

Individuals in this group will receive an identical anesthetic without the addition of remifentanil. They will be given methadone 0.2 mg/kg IV at the beginning of the anesthetic. A lidocaine bolus of 1.5 mg/kg will be given with induction of anesthesia followed by an infusion of lidocaine at 2 mg/kg/hr until the end of surgery.

DRUG

Standard of Care

Standard of Care patients will be given an infusion of remifentanil 0.15-0.25 mcg/kg/min as part of their intraoperative anesthetic regimen. The infusion will be maintained until the end of surgery and will be discontinued upon emergence. Prior to emergence, 100-200 mcg of fentanyl will be titrated for additional analgesia after emergence.

Sponsors & Collaborators

  • Steven Edelstein

    lead OTHER

Principal Investigators

  • Walter Jellish, MD/Ph.D · Loyola University

  • Steven Edelstein, MD · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2021-01-02
Completion
2022-01-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03908944 on ClinicalTrials.gov