Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-31 @ 5:24 AM
Study NCT ID:
NCT02558569
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
Sponsor:
Mahidol University
Organization:
Study Overview
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
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: