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Completed

NCT Number: NCT02057367

Scalp Nerve Block and Opioid Consumption in Brain Surgery

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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chiang Mai University

Chiang Mai, 50200, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalp block with 0.5% plain Marcaine

Drug

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

Other names: Code 1

Scalp block with 0.9% normal saline

Drug

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

Other names: Code 2

Primary outcomes

  1. Intraoperative opioid consumption

    Time frame: During the supratentorial craniotomy surgery

    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 outcomes

  1. systolic blood pressure change

    Time frame: within 5 minutes after skull pin insertion

    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.

  2. Heart rate change

    Time frame: within 5 minutes after skull pin insertion

    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.

Other outcomes

  1. extubation

    Time frame: end of surgery, before transferring to the intensive care unit

    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.

Sponsors and collaborators

Lead sponsor

Chiang Mai University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2014
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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