Scalp Nerve Block and Opioid Consumption in Brain Surgery

NCT ID: NCT02057367

Last Updated: 2016-07-27

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-04-30

Brief Summary

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Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

Detailed Description

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Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

A Prospective Randomized Double Blind Control

Conditions

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Brain Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Scalp block with 0.5% plain marcaine

Anterior scalp block with 0.5% plain Marcaine 20 ml.

Group Type EXPERIMENTAL

Scalp block with 0.5% plain Marcaine

Intervention Type DRUG

Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.

Scalp block with 0.9% normal saline

Anterior scalp block with 0.9% normal saline 20 ml.

Group Type PLACEBO_COMPARATOR

Scalp block with 0.9% normal saline

Intervention Type DRUG

Anterior scalp block will be done by using 0.9% normal saline 20 ml.

Interventions

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Scalp block with 0.5% plain Marcaine

Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.

Intervention Type DRUG

Scalp block with 0.9% normal saline

Anterior scalp block will be done by using 0.9% normal saline 20 ml.

Intervention Type DRUG

Other Intervention Names

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Code 1 Code 2

Eligibility Criteria

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Inclusion Criteria

1. Patients who have supratentorial brain tumor
2. Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
3. Patients have been general anesthetized with endotracheal intubation and control ventilation
4. Patients who have provided consent for the participation in the research and for the use of their medical record in research

Exclusion Criteria

1. Pregnant patients
2. Patients who have a history of local anesthetic allergy and/ or anaphylaxis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

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Pathomporn Pin on, M.D.

Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pathomporn Pin-on, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chiang Mai University

Locations

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Chiang Mai University

Chiang Mai, Chiang Mai, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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ANE2556-01510

Identifier Type: -

Identifier Source: org_study_id

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