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

NCT ID: NCT02558569

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Brain Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Levobupivacaine

Scalp nerve block with 0.5% Levobupivacaine adds up to intravenous fentanyl for intraoperative pain control during supratentorial craniotomy with brain tumor removal. The scalp block includes 4-6 nerves which give sensory supply to related location with the use of total 10-15 ml of 0.5% Levobupivacaine. Intravenous fentanyl is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given. is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given.

Group Type: EXPERIMENTAL

Levobupivacaine

Intervention Type: DRUG

L form of bupivacaine with less cardiotoxicity.

NSS

Scalp nerve block with 10-15 ml of 0.9% sodium chloride(NaCl), or normal saline (NSS) includes 4-6 nerves which give sensory supply to related location (sham block). Intravenous fentanyl is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given.

Group Type: SHAM_COMPARATOR

NSS

Intervention Type: OTHER

Clear intravenous fluid looks alike local anesthetic.

Interventions

Levobupivacaine

L form of bupivacaine with less cardiotoxicity.

Intervention Type: DRUG

NSS

Clear intravenous fluid looks alike local anesthetic.

Intervention Type: OTHER

Other Intervention Names

Chirocaine; 0.9% NaCl or Normal saline

Eligibility Criteria

Inclusion Criteria

• supratentorial brain tumor

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Manee Raksakietisak

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manee Raksakietisak, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Manee Raksakietisak

Bangkok, , Thailand

Siriraj Hospital Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

359/2558(EC3

Identifier Type: -

Identifier Source: org_study_id