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Clinical Trials in Israel / NCT05117034
Active, not recruiting Not applicable

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

NCT05117034 · tracked via the Priya Life Science Israel tracker
Sponsor
Tel-Aviv Sourasky Medical Center
Phase
Not applicable
Started
2022-02-16
Last updated
2024-11-20

Condition(s) studied

Pain, PostoperativeAnesthesiaAnalgesia

Investigational drug(s) / intervention(s)

Morphine →Nacl 0.9% →

Morphine: Intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure.

Nacl 0.9%: Intraoperative intravenous administration of 0.08 ml/kg NaCl 0.9% at dura closure.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • First NRS pain score. — Up to 1 hour from PACU admission
    The numeric rating scale (NRS), a validated tool used to assess patients' self-reported pain level, will be taken at admission to the post anesthesia care unit (PACU). NRS score ranges from 0 to 10, with higher scores representing worse pain.

Trial sites (1)

FacilityCityRegionStatus
Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel Tel Aviv Israel

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05117034 on ClinicalTrials.gov ↗ ← All trials in Israel