Scalp Nerve Block and Opioid Consumption in Brain Surgery

Brain Tumour Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057367
• Other study ID #: ANE2556-01510
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2013
• Last updated: July 25, 2016
• Start date: March 2013
• Est. completion date: April 2016

Study information

• Verified date: July 2016
• Source: Chiang Mai University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumour

Intervention

Drug:
• Scalp block with 0.5% plain Marcaine
Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.
• Scalp block with 0.9% normal saline
Anterior scalp block will be done by using 0.9% normal saline 20 ml.

Locations

Country	Name	City	State
Thailand	Chiang Mai University	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	extubation	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.	end of surgery, before transferring to the intensive care unit	No
Primary	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.	During the supratentorial craniotomy surgery	No
Secondary	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.	within 5 minutes after skull pin insertion	No
Secondary	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.	within 5 minutes after skull pin insertion	No