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Scalp Nerve Block and Opioid Consumption in Brain Surgery

Primary Purpose

Brain Tumour

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Scalp block with 0.5% plain Marcaine
Scalp block with 0.9% normal saline
Sponsored by
Chiang Mai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumour focused on measuring supratentorial brain tumour, craniotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chiang Mai University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Scalp block with 0.5% plain marcaine

Scalp block with 0.9% normal saline

Arm Description

Anterior scalp block with 0.5% plain Marcaine 20 ml.

Anterior scalp block with 0.9% normal saline 20 ml.

Outcomes

Primary Outcome Measures

Intraoperative opioid consumption
The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.

Secondary Outcome Measures

systolic blood pressure change
The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded. The systolic blood pressure change from baseline will be calculated. The unit is mmHg.
Heart rate change
The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded. The heart rate change from baseline level will be calculated. The unit is beats per minute.

Full Information

First Posted
September 26, 2013
Last Updated
July 25, 2016
Sponsor
Chiang Mai University
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1. Study Identification

Unique Protocol Identification Number
NCT02057367
Brief Title
Scalp Nerve Block and Opioid Consumption in Brain Surgery
Official Title
The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiang Mai University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumour
Keywords
supratentorial brain tumour, craniotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scalp block with 0.5% plain marcaine
Arm Type
Experimental
Arm Description
Anterior scalp block with 0.5% plain Marcaine 20 ml.
Arm Title
Scalp block with 0.9% normal saline
Arm Type
Placebo Comparator
Arm Description
Anterior scalp block with 0.9% normal saline 20 ml.
Intervention Type
Drug
Intervention Name(s)
Scalp block with 0.5% plain Marcaine
Other Intervention Name(s)
Code 1
Intervention Description
Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.
Intervention Type
Drug
Intervention Name(s)
Scalp block with 0.9% normal saline
Other Intervention Name(s)
Code 2
Intervention Description
Anterior scalp block will be done by using 0.9% normal saline 20 ml.
Primary Outcome Measure Information:
Title
Intraoperative opioid consumption
Description
The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.
Time Frame
During the supratentorial craniotomy surgery
Secondary Outcome Measure Information:
Title
systolic blood pressure change
Description
The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded. The systolic blood pressure change from baseline will be calculated. The unit is mmHg.
Time Frame
within 5 minutes after skull pin insertion
Title
Heart rate change
Description
The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded. The heart rate change from baseline level will be calculated. The unit is beats per minute.
Time Frame
within 5 minutes after skull pin insertion
Other Pre-specified Outcome Measures:
Title
extubation
Description
The rate of immediate extubation before transferring to the intensive care unit (ICU) compared between patients who received 0.5% plain Marcaine and 0.9% normal saline solution.
Time Frame
end of surgery, before transferring to the intensive care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have supratentorial brain tumor Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position Patients have been general anesthetized with endotracheal intubation and control ventilation Patients who have provided consent for the participation in the research and for the use of their medical record in research Exclusion Criteria: Pregnant patients Patients who have a history of local anesthetic allergy and/ or anaphylaxis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pathomporn Pin-on, M.D.
Organizational Affiliation
Chiang Mai University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiang Mai University
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

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Scalp Nerve Block and Opioid Consumption in Brain Surgery

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