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

Primary Purpose

Brain Tumor

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Levobupivacaine
NSS
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring fentanyl, scalp block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • supratentorial brain tumor

Exclusion Criteria:

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

Sites / Locations

  • Manee Raksakietisak
  • Siriraj Hospital Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Levobupivacaine

NSS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The total dose of fentanyl being used during craniotomy
Total dose of fentanyl use during operative period

Secondary Outcome Measures

Awakening time from general anesthesia
Time from the end of anesthetic to fully awake and extubation

Full Information

First Posted
September 22, 2015
Last Updated
September 13, 2016
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02558569
Brief Title
The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
Official Title
The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
fentanyl, scalp block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levobupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
NSS
Arm Type
Sham Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Levobupivacaine
Other Intervention Name(s)
Chirocaine
Intervention Description
L form of bupivacaine with less cardiotoxicity.
Intervention Type
Other
Intervention Name(s)
NSS
Other Intervention Name(s)
0.9% NaCl or Normal saline
Intervention Description
Clear intravenous fluid looks alike local anesthetic.
Primary Outcome Measure Information:
Title
The total dose of fentanyl being used during craniotomy
Description
Total dose of fentanyl use during operative period
Time Frame
One day
Secondary Outcome Measure Information:
Title
Awakening time from general anesthesia
Description
Time from the end of anesthetic to fully awake and extubation
Time Frame
One day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manee Raksakietisak, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manee Raksakietisak
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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

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