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

NCT ID: NCT02880566

Last Updated: 2016-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Craniotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment

Full scalp block performed with a total of 30 ml of levobupivacaine 0.33 %.

Group Type EXPERIMENTAL

Scalp block

Intervention Type PROCEDURE

Full scalp block

Control

Full scalp block performed with a total of 30 ml of normal saline.

Group Type PLACEBO_COMPARATOR

Scalp block

Intervention Type PROCEDURE

Full scalp block

Interventions

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Scalp block

Full scalp block

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective craniotomy for supratentorial lesion

Exclusion Criteria

* Allergy to local anaesthetic
* Psychiatric disease
* Inability to consent
* Uncontrolled intracranial hypertension
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean François Brichant

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.

Reference Type DERIVED
PMID: 33060491 (View on PubMed)

Other Identifiers

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anesneuro2016001

Identifier Type: -

Identifier Source: org_study_id

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