Status:
COMPLETED
Scalp Nerve Blocks for Post-Craniotomy Pain
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Supratentorial Neoplasms
Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to demonstrate that scalp nerve blocks ("scalp freezing"), performed at the end of supratentorial brain surgery, will reduce post-operative pain, opioids side effects, a...
Detailed Description
The proposed study is a randomized, placebo-controlled, triple-blinded, parallel-group clinical trial. Patients will be recruited from the neurosurgical population at St. Michael's Hospital. The incl...
Eligibility Criteria
Inclusion
- adults aged 18 years and over;
- patients scheduled for elective craniotomy under general anaesthesia for one of the following surgeries:
- resection of a supratentorial brain tumour,
- clipping of an un-ruptured supratentorial cerebral aneurysm,
- excision of a supratentorial arterio-venous malformation (AVM),
- removal of an epileptic focus under general anaesthetic.
- ASA physical status \< IV.
Exclusion
- history of significant coronary artery disease (NYHA class III or IV) which would contraindicate the use of epinephrine;
- presence of pain related to the intracranial pathology (e.g. tumour pain) since it could make difficult the discrimination between the tumour pain itself and the surgery related pain;
- current history of alcohol abuse or recreational drug abuse;
- active psychotic disorder;
- history of chronic pain requiring chronic opioids use (patients on opioids for \> 2 weeks);
- known or suspected addiction to narcotic substances;
- presence of any acute distracting pain;
- history of migraines;
- inability to understand or incapacity to use the VAS;
- proven or suspected allergy to local anaesthetics;
- craniotomy incision extending beyond the field of the block;
- predicted need for postoperative ventilation;
- history of scalp paresthesia or scalp scarring that may preclude normal nerve anatomy;
- previous craniotomy or cranial irradiation;
- history of malignant hyperthermia, which would contraindicate the anaesthesia maintenance protocol of this study;
- pregnancy.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00972790
Start Date
March 1 2010
End Date
December 1 2011
Last Update
March 1 2012
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8