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

Not Applicable

Recruiting

• Conditions: Dexmedetomidine; Adjuvant; Bupivacaine; Scalp Block; Postoperative Pain; Craniotomy

• Registration Number: NCT06993922
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.

The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Study Start: 2025-05-29
• Study First Posted: 2025-05-29
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative postoperative morphine consumption	24 hours postoperatively	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

Secondary Outcome Measures

Name	Time	Method
Time for 1st rescue analgesia	24 hours postoperatively	Time for 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Incidence of complications	24 hours postoperatively	Incidence of complications such as postoperative nausea and vomiting, respiratory depression, or any other complication will be recorded.
Heart rate	24 hours postoperatively	Heart rate will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and 2, 4, 6, 12, and 24 hours postoperatively.
Degree of pain	24 hours postoperatively	Pain intensity will be evaluated on a 0-10 visual analog scale (VAS). The VAS consists of a 10 cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). The VAS score will be recorded at baseline (after admission to PACU), then after 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, and 24 hours postoperatively.
Mean arterial pressure	24 hours postoperatively	Mean arterial pressure will be measured at baseline, before Mayfield placement, 5 minutes after Mayfield insertion, at the end of surgery, and postoperatively at 2, 4, 6,12, and 24 hours postoperatively.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt