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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

Tracking Information
First Submitted Date  ICMJE September 26, 2013
First Posted Date  ICMJE February 7, 2014
Last Update Posted Date July 27, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2014)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Scalp Nerve Block and Opioid Consumption in Brain Surgery
Official Title  ICMJE 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
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).
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Tumour
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Scalp block with 0.5% plain marcaine
    Anterior scalp block with 0.5% plain Marcaine 20 ml.
    Intervention: Drug: Scalp block with 0.5% plain Marcaine
  • Placebo Comparator: Scalp block with 0.9% normal saline
    Anterior scalp block with 0.9% normal saline 20 ml.
    Intervention: Drug: Scalp block with 0.9% normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2016)
100
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
95
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057367
Other Study ID Numbers  ICMJE ANE2556-01510
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pathomporn Pin on, M.D., Chiang Mai University
Study Sponsor  ICMJE Chiang Mai University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pathomporn Pin-on, M.D. Chiang Mai University
PRS Account Chiang Mai University
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP