Comparison of Systemic Opioid (Morphine) and Pre-Incision Bilateral Scalp Nerve Block for Pain Management in Craniotomy Patients
NCT07425678 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2026-02-23
Summary
The goal of this randomized controlled clinical trial is to compare the effectiveness of systemic opioids versus pre-incision bilateral scalp nerve block in managing intraoperative noxious stimuli and postoperative pain in adult patients (18-75 years) undergoing elective supratentorial craniotomy.
The main questions this study aims to answer are:
Does pre-incision bilateral scalp nerve block provide better intraoperative hemodynamic stability compared to systemic opioids?
Does it result in lower postoperative pain scores and reduced opioid consumption during the first 24 hours after surgery?
Researchers will compare Group M (systemic morphine) with Group S (bilateral scalp nerve block) to see if the scalp nerve block offers superior analgesia and fewer opioid-related side effects.
Participants will:
Be randomly assigned to receive either systemic morphine or bilateral scalp nerve block before incision.
Undergo standard general anesthesia for craniotomy.
Have postoperative pain managed using a patient-controlled analgesia (PCA) morphine pump and be monitored for 24 hours for pain, sedation, and nausea/vomiting scores
Conditions
- Supratentorial Tumors
Interventions
- PROCEDURE
-
Scalp nerve block
Bilateral block of the following nerves: * Supraorbital nerve * Supratrochlear nerve * Auriculotemporal nerve * Zygomaticotemporal nerve * Greater occipital nerve * Lesser occipital nerve
- DRUG
-
Morphine
Drug: Morphine Dose: 0.1 mg/kg Route: Intravenous Timing: At induction of anesthesia
- DRUG
-
Lidocaine
Concentration: 0.1% Route: Local infiltration Used as part of scalp block mixture
- DRUG
-
Ropivacaine
Concentration: 0.25% Route: Local infiltration Used as part of scalp block mixture
- DRUG
-
Epinephrine (Adrenaline)
Concentration: 1:200,000 Route: Local infiltration Used as vasoconstrictor adjunct
- DRUG
-
Dose: 4 mg Route: Local Infiltration Used as adjunct to prolong block duration
Sponsors & Collaborators
-
Aga Khan University
lead OTHER
Principal Investigators
-
Dileep Kumar, MBBS, FCPS · Aga Khan University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-01
- Primary Completion
- 2025-07-01
- Completion
- 2025-09-30
Countries
- Pakistan
Study Locations
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