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Completed

NCT Number: NCT02558569

The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block

This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor patients. The control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive scalp nerve block with 0.5% levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general anesthesia.

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Key information

Conditions

Brain Tumor 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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Manee Raksakietisak, Bangkok, Thailand

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About this study

Fentanyl has widely been used for intraoperative analgesia for craniotomy. In craniotomy, the long and complex operation, the continuous infusion or repeated use of fentanyl can significantly delay emergence from general anesthesia. The scalp block with local anesthesia is widely used for awake craniotomy with great success but it is not routinely used in general craniotomy. In this study, the control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive the addition of scalp nerve block with 0.5% levobupivacaine (local anesthetic). The scalp nerve block might reduce the total dose of fentanyl and promote faster emergence from general anesthesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • supratentorial brain tumor

Exclusion criteria

  • tumor size>4 cm
  • Glasgow Coma Score (GCS) <15
  • already intubated
  • uncontrolled hypertension
  • can not communicate

Treatment and study plan

Levobupivacaine

Drug

L form of bupivacaine with less cardiotoxicity.

Other names: Chirocaine

NSS

Other

Clear intravenous fluid looks alike local anesthetic.

Other names: 0.9% NaCl or Normal saline

Primary outcomes

  1. The total dose of fentanyl being used during craniotomy

    Time frame: One day

    Total dose of fentanyl use during operative period

Secondary outcomes

  1. Awakening time from general anesthesia

    Time frame: One day

    Time from the end of anesthetic to fully awake and extubation

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 24, 2015
Registry last updated
Sep 14, 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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