Scalp Nerve Block and Opioid Consumption in Brain Surgery
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|ClinicalTrials.gov Identifier: NCT02057367|
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : July 27, 2016
|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|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
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
|Chiang Mai University|
|Chiang Mai, Thailand, 50200|
|Principal Investigator:||Pathomporn Pin-on, M.D.||Chiang Mai University|