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

August 23, 2016 updated by: Jean François Brichant, University of Liege
Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective craniotomy for supratentorial lesion

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic stability
Time Frame: 5 minutes
Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning
5 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative intraoperative remifentanil consumption
Time Frame: 24 hours
24 hours
Cumulative postoperative morphine consumption
Time Frame: 48 hours
48 hours
Postoperative pain scores
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 23, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 23, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • anesneuro2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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