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

• Sponsor: University of Liege (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02880566
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Craniotomy	Procedure: Scalp block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2016
• Anticipated Primary Completion Date: Sep 1, 2017
• Anticipated Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Full scalp block performed with a total of 30 ml of levobupivacaine 0.33 %.	Procedure: Scalp block; Full scalp block
Placebo Comparator: Control Full scalp block performed with a total of 30 ml of normal saline.	Procedure: Scalp block; Full scalp block

Outcome Measures

Primary Outcome Measures

1. 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

1. Cumulative intraoperative remifentanil consumption [24 hours]

2. Cumulative postoperative morphine consumption [48 hours]

3. Postoperative pain scores [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective craniotomy for supratentorial lesion

Exclusion Criteria:

• Allergy to local anaesthetic

• Psychiatric disease

• Inability to consent

• Uncontrolled intracranial hypertension

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jean François Brichant, Professor and Chair, University of Liege
• ClinicalTrials.gov Identifier: NCT02880566
• Other Study ID Numbers: anesneuro2016001
• First Posted: Aug 26, 2016
• Last Update Posted: Aug 26, 2016
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Aug 26, 2016