Active — Not RecruitingNot Applicable

Pre-emptive Intravenous Morphine for Acute Post-craniotomy Pain.

Israel115 participantsStarted 2022-02-16

Plain-language summary

We propose a double-blind randomized controlled trial to evaluate the effect of intravenously administered morphine at surgery conclusion on acute postoperative pain in patients recovering from craniotomy surgery. Participating adults having craniotomy surgery will be randomized in a 1:1 ratio to intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure, or a matching placebo.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed consent. * Scheduled for elective craniotomy for resection of supra-tentorial intracranial tumor that requires cranium sawing, dural opening and excision of tumor, under general anesthesia. * Age 18 - 80 years. * American Society of Anesthesiologists' physical status I-III. * Body mass index (BMI) under 35 kg/m2. Exclusion Criteria: * Pregnant or current breastfeeding patients. * Patients unable to provide informed consent or in need of a legal authorized representative. * Patients with neurological disorders preventing a good understanding of the pain numerical reporting scale (NRS) before surgery. * Patients with pre-operative aphasia. * Patients with chronic pain or chronic use of opioids. * Patients with current alcohol or drug abuse. * Expected delayed extubation. * Patients with documented allergy to opioids or acetaminophen. * Preoperative Glasgow Coma Scale \<15.

What they're measuring

First NRS pain score.

Timeframe: Up to 1 hour from PACU admission

Trial details

NCT IDNCT05117034

SponsorTel-Aviv Sourasky Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-05-01

View on ClinicalTrials.gov More Pain, Postoperative trials