The Efficacy of Scalp Block in Craniotomy

NCT06951230 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS72/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the effectiveness and safety of scalp block versus intravenous fentanyl in pain control intraoperatively in craniotomy patients. Most of the previous studies compared the effect of scalp block versus fentanyl or opioids in postoperative pain

Conditions

Post-operative Pain; Narcotics Consumption; Pain Assessment; Intraoperative Hemodynamic Instability

Keywords

scalp block; pain; craniotomy; Pain control

Outcome Measures

Primary Outcomes (1)

• intra-operative hemodynamic stability

  Recording the mean arterial blood pressure and heart rate readings will be obtained before induction , on skin pinning, on skin incision , 1 hour post induction, after 2hours and every hour hour till the end of the surgery

  intra-operatively

Secondary Outcomes (1)

• fentanyl consumption

  intra-operatively

Other Outcomes (1)

• post-operative pain

  1 hour post-operatively

Study Arms (2)

fentanyl group

ACTIVE COMPARATOR

patients will receive general anesthesia followed by intravenous fentanyl (1ug/kg/hr)

Drug: Fentanyl injection

scalp block group

ACTIVE COMPARATOR

patients will receive general anesthesia followed by the scalp block.

Drug: Fentanyl injection; Procedure: scalp block

Interventions

Fentanyl injection DRUG

Fentanyl 1mcg/kg will be given before skin incision and Mayfield placement and followed up by fentanyl 1mcg/kg/hr, along the operation.

fentanyl group; scalp block group

scalp block PROCEDURE

The scalp block procedure is performed with the patient in the supine position, utilizing surface landmarks for guidance. The local anesthetic is injected into the nerves after careful aspiration and under strict aseptic technique. The nerves that are typically injected include the supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, as well as the lesser and greater occipital nerves, with or without the inclusion of the third occipital nerve. The volume of 0.5% bupivacaine injected should not exceed 2 ml at each site.

scalp block group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 20 and 60
• Physical status: ASA I and II
• Elective operation, under general anaesthesia,

You may not qualify if:

• ASA above ll
• Patients with known uncontrolled comorbidities such as hypertension or Diabetes Mellites
• Coagulopathy, use of anti-coagulant or anti-platelet therapy.
• Known allergies to drugs used (Bupivacaine)
• Infection at the site of injection
• History of cranial nerve affection
• Emergency craniotomy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Agnosia

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hegazy

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 30, 2025
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: before 6/2025
• Access Criteria: free

Locations

EG (1)