The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Levobupivacaine
- Conditions
- Brain Tumor
- Sponsor
- Mahidol University
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- The total dose of fentanyl being used during craniotomy
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Manee Raksakietisak
Associate professor
Mahidol University
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
Arms & Interventions
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.
Intervention: Levobupivacaine
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.
Intervention: NSS
Outcomes
Primary Outcomes
The total dose of fentanyl being used during craniotomy
Time Frame: One day
Total dose of fentanyl use during operative period
Secondary Outcomes
- Awakening time from general anesthesia(One day)