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

NCT05117034 | Active Not Recruiting

• 1 other identifier: 0193-21-TLV-OG
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Anesthesia; Analgesia

Keywords

Craniotomy; Post-craniotomy pain; Opioid analgesia

Outcome Measures

Primary Outcomes (1)

• First NRS pain score.

  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.

  Up to 1 hour from PACU admission

Secondary Outcomes (2)

• Time to first rescue morphine administration

  During 2 hours from PACU admission.

• Total morphine consumption

  During 2 hours from PACU admission.

Other Outcomes (6)

• Systolic and mean arterial pressure.

  During 30 minutes from PACU admission.

• Time-weighted average NRS pain score during the first two postoperative days.

  During 48 hours from PACU admission.

• NRS pain score 30 minutes after admission to PACU.

  During 30 minutes from PACU admission.

Study Arms (2)

Morphine

EXPERIMENTAL

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

Drug: Morphine

Placebo

PLACEBO COMPARATOR

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

Drug: Nacl 0.9%

Interventions

Morphine DRUG

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

Morphine

Nacl 0.9% DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

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

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Morphine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Or Goren, MD

  Department of Anesthesia, Intensive Care, and Pain Management, Tel-Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chair, department of Anesthesia, Intensive Care, and Pain Management

Model Details: A double-blind randomized controlled trial. 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.

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 11, 2021
• Study Start: February 16, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

IL (1)