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Scalp Nerve Block and Opioid Consumption in Brain Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057367
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
Pathomporn Pin on, M.D., Chiang Mai University

Brief Summary:
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

Condition or disease Intervention/treatment Phase
Brain Tumour Drug: Scalp block with 0.5% plain Marcaine Drug: Scalp block with 0.9% normal saline Phase 4

Detailed Description:

Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).

A Prospective Randomized Double Blind Control

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled
Study Start Date : March 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: Scalp block with 0.5% plain marcaine
Anterior scalp block with 0.5% plain Marcaine 20 ml.
Drug: Scalp block with 0.5% plain Marcaine
Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.
Other Name: Code 1

Placebo Comparator: Scalp block with 0.9% normal saline
Anterior scalp block with 0.9% normal saline 20 ml.
Drug: Scalp block with 0.9% normal saline
Anterior scalp block will be done by using 0.9% normal saline 20 ml.
Other Name: Code 2




Primary Outcome Measures :
  1. Intraoperative opioid consumption [ Time Frame: During the supratentorial craniotomy surgery ]
    The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.


Secondary Outcome Measures :
  1. systolic blood pressure change [ Time Frame: within 5 minutes after skull pin insertion ]

    The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded.

    The systolic blood pressure change from baseline will be calculated. The unit is mmHg.


  2. Heart rate change [ Time Frame: within 5 minutes after skull pin insertion ]

    The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded.

    The heart rate change from baseline level will be calculated. The unit is beats per minute.



Other Outcome Measures:
  1. extubation [ Time Frame: end of surgery, before transferring to the intensive care unit ]
    The rate of immediate extubation before transferring to the intensive care unit (ICU) compared between patients who received 0.5% plain Marcaine and 0.9% normal saline solution.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients who have supratentorial brain tumor
  2. Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
  3. Patients have been general anesthetized with endotracheal intubation and control ventilation
  4. Patients who have provided consent for the participation in the research and for the use of their medical record in research

Exclusion Criteria:

  1. Pregnant patients
  2. Patients who have a history of local anesthetic allergy and/ or anaphylaxis

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): NCT02057367


Locations
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Thailand
Chiang Mai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Chiang Mai University
Investigators
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Principal Investigator: Pathomporn Pin-on, M.D. Chiang Mai University
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Responsible Party: Pathomporn Pin on, M.D., Department of Anesthesiology, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02057367    
Other Study ID Numbers: ANE2556-01510
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pathomporn Pin on, M.D., Chiang Mai University:
supratentorial brain tumour
craniotomy
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents