Scalp Nerve Block and Opioid Consumption in Brain Surgery

NCT02057367 | Completed Phase 4 DMC

• 1 other identifier: ANE2556-01510
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Tumour

Keywords

supratentorial brain tumour; craniotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• systolic blood pressure change

  within 5 minutes after skull pin insertion

• Heart rate change

  within 5 minutes after skull pin insertion

Other Outcomes (1)

• extubation

  end of surgery, before transferring to the intensive care unit

Study Arms (2)

Scalp block with 0.5% plain marcaine

EXPERIMENTAL

Anterior scalp block with 0.5% plain Marcaine 20 ml.

Drug: Scalp block with 0.5% plain Marcaine

Scalp block with 0.9% normal saline

PLACEBO COMPARATOR

Anterior scalp block with 0.9% normal saline 20 ml.

Drug: Scalp block with 0.9% normal saline

Interventions

Scalp block with 0.5% plain Marcaine DRUG

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

Also known as: Code 1

Scalp block with 0.5% plain marcaine

Scalp block with 0.9% normal saline DRUG

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

Also known as: Code 2

Scalp block with 0.9% normal saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant patients
• Patients who have a history of local anesthetic allergy and/ or anaphylaxis

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Chiang Mai University

Chiang Mai, Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Saline Solution; PAVE protocol 2

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Pathomporn Pin-on, M.D.

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: February 7, 2014
• Study Start: March 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 27, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)