Scalp Nerve Block and Opioid Consumption in Brain Surgery

• ClinicalTrials.gov Identifier: NCT02057367
• Recruitment Status: Completed
• First Posted: February 7, 2014
• Last Update Posted: July 27, 2016
• Sponsor: Chiang Mai University
• Information provided by (Responsible Party): Pathomporn Pin on, M.D., Chiang Mai University

Tracking Information

• First Submitted Date: September 26, 2013
• First Posted Date: February 7, 2014
• Last Update Posted Date: July 27, 2016
• Study Start Date: March 2013
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: Scalp Nerve Block and Opioid Consumption in Brain Surgery
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Brain Tumour

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 25, 2016): 100
• Original Estimated Enrollment (submitted: February 6, 2014): 95
• Actual Study Completion Date: April 2016
• Actual Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT02057367
• Other Study ID Numbers: ANE2556-01510
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Pathomporn Pin on, M.D., Chiang Mai University
• Study Sponsor: Chiang Mai University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Pathomporn Pin-on, M.D.; Chiang Mai University

• PRS Account: Chiang Mai University
• Verification Date: July 2016