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NCT02880566 Clinical Trial

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

Craniotomy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02880566
Other study ID # anesneuro2016001
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 23, 2016
Last updated August 23, 2016
Start date September 2016
Est. completion date September 2017

Study information
Verified date August 2016
Source University Hospital of Liege
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective craniotomy for supratentorial lesion

Exclusion Criteria:

- Allergy to local anaesthetic

- Psychiatric disease

- Inability to consent

- Uncontrolled intracranial hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Scalp block
Full scalp block

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Liege

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodynamic stability Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning 5 minutes No
Secondary Cumulative intraoperative remifentanil consumption 24 hours No
Secondary Cumulative postoperative morphine consumption 48 hours No
Secondary Postoperative pain scores 48 hours No
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