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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558569
• Other study ID #: 359/2558(EC3
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2015
• Last updated: September 13, 2016
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• supratentorial brain tumor

Exclusion Criteria:

• tumor size>4 cm

• Glasgow Coma Score (GCS) <15

• already intubated

• uncontrolled hypertension

• can not communicate

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

Intervention

Drug:
• Levobupivacaine
L form of bupivacaine with less cardiotoxicity.

Other:
• NSS
Clear intravenous fluid looks alike local anesthetic.

Locations

Country	Name	City	State
Thailand	Manee Raksakietisak	Bangkok
Thailand	Siriraj Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total dose of fentanyl being used during craniotomy	Total dose of fentanyl use during operative period	One day	Yes
Secondary	Awakening time from general anesthesia	Time from the end of anesthetic to fully awake and extubation	One day	Yes