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, and the time required for post-anaesthesia care unit (PACU)/Intensive Care Unit (ICU) and hospital discharge.
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 inclusion criteria are: * Adults aged 18 years and over; * scheduled for one of the following supratentorial craniotomy: 1. resection of a brain tumour 2. clipping of an un-ruptured cerebral aneurysm 3. excision of an artero-venous malformation (AVM), or 4. removal of an epileptic focus * ASA physical status \< IV Intervention group: scalp nerve blocks with 20 ml of bupivacaine 0.5% + epinephrine 1:200,000 (divided among the different injection sites) at the end of surgery and before removal of the endo-tracheal tube. Control group: equal injections with 20 ml of saline + epinephrine 1:200,000 (at same time). In both study arms, post-operative rescue analgesia will be provided with hydromorphone patient-controlled analgesia (PCA). The primary outcome of this study will be the 24h post-operative pain score as assessed by the visual analogue scale (VAS). Important secondary outcomes will be: * the total PCA hydromorphone consumption in the first 24 and 48 post-operative hours; * the incidence of nausea and vomiting in the first 24 and 48 post-operative hours; * time to reach discharge eligibility from the PACU/ICU and hospital length of stay. Patients will be asked to rate their pain using the VAS at 30 min, 1, 2, 4, 8, 12, 18, 24, and 48 h, postoperatively by the research coordinator/bedside nurse. Pain will be also assessed at 5, 30 and 60 days postoperatively with the use of a Numeric Rating Scale (0-10).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
89
Scalp nerve blocks will be performed bilaterally at the end of the surgery under general anaesthesia and before removal of the head holder. Patients will receive scalp nerve blocks with a total of 20 ml of 0.5% bupivacaine + epinephrine 1:200,000 or 20 ml of saline + epinephrine 1:200,000. Solution volume is as follows: 2ml each bilaterally for supraorbital and supratrochlear nerves; 3 ml for the auriculotemporal nerves; 2 ml for the postauricular branches of the greater auricular nerves and for the greater, lesser, and third occipital nerves 3 ml of solution will be infiltrated along the superior nuchal line, approximately halfway between the occipital protuberance and the mastoid process.
St. Michael's Hospital
Toronto, Ontario, Canada
The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
Time frame: 24 hours
48h post-operative pooled VAS score
Time frame: 48 hours
the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
Time frame: 24 and 48 hours
total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours
Time frame: 24 and 48 hours
the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
Time frame: 24 and 48 hours
the time for patients to reach discharge eligibility from the PACU/ICU
Time frame: Discharge time and date from PACU/ICU
the time for patients to reach discharge eligibility from hospital
Time frame: Discharge time and date from hospital
presence of long term pain as measured with the Numeric Rating Scale (NRS) at days 5, 30 and 60 postoperatively
Time frame: 5, 30 and 60 days
Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5
Time frame: day 5
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