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

Brain Tumor Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

• NCT number: NCT02558569
• Study type: Interventional
• Source: Mahidol University
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Completion date: August 2016