NCT02558569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

September 22, 2015

Last Update Submit

September 13, 2016

Conditions

Brain Tumor

Keywords

fentanyl, scalp block

Outcome Measures

Primary Outcomes (1)

  • The total dose of fentanyl being used during craniotomy

    Total dose of fentanyl use during operative period

    One day

Secondary Outcomes (1)

  • Awakening time from general anesthesia

    One day

Study Arms (2)

Levobupivacaine

EXPERIMENTAL

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.

Drug: Levobupivacaine

NSS

SHAM COMPARATOR

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.

Other: NSS

Interventions

LevobupivacaineDRUG

L form of bupivacaine with less cardiotoxicity.

Also known as: Chirocaine
Levobupivacaine
NSSOTHER

Clear intravenous fluid looks alike local anesthetic.

Also known as: 0.9% NaCl or Normal saline
NSS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • supratentorial brain tumor

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Manee Raksakietisak

Bangkok, 10700, Thailand

Location

Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

LevobupivacaineSaline Solution

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Manee Raksakietisak, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 22, 2015

First Posted

September 24, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

TH(2)