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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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ClinicalTrials.gov Identifier: NCT02558569
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Manee Raksakietisak, Mahidol University

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Drug: Levobupivacaine Other: NSS Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial
Study Start Date : September 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Levobupivacaine
L form of bupivacaine with less cardiotoxicity.
Other Name: Chirocaine

Sham Comparator: 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.
Other: NSS
Clear intravenous fluid looks alike local anesthetic.
Other Name: 0.9% NaCl or Normal saline




Primary Outcome Measures :
  1. The total dose of fentanyl being used during craniotomy [ Time Frame: One day ]
    Total dose of fentanyl use during operative period


Secondary Outcome Measures :
  1. Awakening time from general anesthesia [ Time Frame: One day ]
    Time from the end of anesthetic to fully awake and extubation



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • supratentorial brain tumor

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558569


Locations
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Thailand
Manee Raksakietisak
Bangkok, Thailand, 10700
Siriraj Hospital Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Manee Raksakietisak, MD Mahidol University

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Responsible Party: Manee Raksakietisak, Associate professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02558569     History of Changes
Other Study ID Numbers: 359/2558(EC3
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Keywords provided by Manee Raksakietisak, Mahidol University:
fentanyl, scalp block

Additional relevant MeSH terms:
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Fentanyl
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Local