Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy

NCT06993922 | Recruiting

• 1 other identifier: FMASU MS 57/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.

Conditions

Dexmedetomidine; Adjuvant; Bupivacaine; Scalp Block; Postoperative Pain; Craniotomy

Outcome Measures

Primary Outcomes (1)

• Cumulative postoperative morphine consumption

  If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg

  24 hours postoperatively

Secondary Outcomes (5)

• Mean arterial pressure

  24 hours postoperatively

• Heart rate

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

• Time for 1st rescue analgesia

  24 hours postoperatively

• Incidence of complications

  24 hours postoperatively

Study Arms (2)

Group SB

ACTIVE COMPARATOR

Patients will receive a scalp block with bupivacaine alone.

Other: Scalp block

Group SD

EXPERIMENTAL

Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Other: Scalp block + Dexmedetomidine

Interventions

Scalp block OTHER

Patients will receive a scalp block with bupivacaine alone.

Also known as: Bupivacaine

Group SB

Scalp block + Dexmedetomidine OTHER

Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.

Also known as: Bupivacaine + Dexmedetomidine

Group SD

Eligibility Criteria

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

You may qualify if:

• Age from 18 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I or II.
• Undergoing supratentorial elective planned craniotomies.

You may not qualify if:

• Patients refusal.
• History of known allergy to the used local anesthetic or dexmedetomidine.
• Bleeding disorders.
• Evidence of local infection at the site of injection.
• Emergency craniotomy.
• Psychotic disorder.
• Patients who will not be extubated in the operating room after surgery.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Omar A Khiralla, MBBCH

CONTACT

00201095281838; Omar-Ahmed@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anaesthesia, Intensive Care Unit and Pain, Faculty of Medicine, Ain shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: May 29, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)