Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy

Not Applicable

• Conditions: Craniotomy
• Interventions: Procedure: Scalp block

• Registration Number: NCT02880566
• Lead Sponsor: University of Liege

Brief Summary

Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-23
• Last Update Submitted: 2016-08-23
• Study First Posted: 2016-08-26
• Last Update Posted: 2016-08-26
• Study Start: 2016-09
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

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

Inclusion Criteria

• Elective craniotomy for supratentorial lesion

Exclusion Criteria

• Allergy to local anaesthetic
• Psychiatric disease
• Inability to consent
• Uncontrolled intracranial hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Scalp block	Full scalp block performed with a total of 30 ml of levobupivacaine 0.33 %.
Control	Scalp block	Full scalp block performed with a total of 30 ml of normal saline.

Primary Outcome Measures

Name	Time	Method
Hemodynamic stability	5 minutes	Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning

Secondary Outcome Measures

Name	Time	Method
Cumulative intraoperative remifentanil consumption	24 hours
Postoperative pain scores	48 hours
Cumulative postoperative morphine consumption	48 hours