Scalp Nerve Block and Opioid Consumption in Brain Surgery

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

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).

Study Overview

• Status: Completed
• Conditions: Brain Tumour
• Intervention / Treatment: Drug: Scalp block with 0.5% plain Marcaine; Drug: Scalp block with 0.9% normal saline

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Scalp block with 0.5% plain marcaine; Anterior scalp block with 0.5% plain Marcaine 20 ml.	Drug: Scalp block with 0.5% plain Marcaine; Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.; Other Names: Code 1
PLACEBO_COMPARATOR: Scalp block with 0.9% normal saline; Anterior scalp block with 0.9% normal saline 20 ml.	Drug: Scalp block with 0.9% normal saline; Anterior scalp block will be done by using 0.9% normal saline 20 ml.; Other Names: Code 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Investigators: Principal Investigator: Pathomporn Pin-on, M.D., Chiang Mai University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (ESTIMATE): February 7, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 27, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: craniotomy; supratentorial brain tumour
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ANE2556-01510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO