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| Name | Class |
|---|---|
| The Physicians' Services Incorporated Foundation | OTHER |
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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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Sham Comparator | The patients in the control arm will receive sham nerve blocks with 20 ml of saline + epinephrine 1:200,000, in a manner identical to that described for the treatment group. |
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| Intervention Group | Active Comparator | The patients in the intervention group will receive bilateral scalp nerve blocks with a total of 20 ml of 0.5% bupivacaine + epinephrine 1:200,000. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Scalp Nerve Blocks | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 48h post-operative pooled VAS score | 48 hours | |
| the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours | 24 and 48 hours | |
| total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours |
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Inclusion Criteria:
adults aged 18 years and over;
patients scheduled for elective craniotomy under general anaesthesia for one of the following surgeries:
ASA physical status < IV.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Rigamonti, MD, MSc (c) | St. Michael's Hospital, University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31879855 | Derived | Rigamonti A, Garavaglia MM, Ma K, Crescini C, Mistry N, Thorpe K, Cusimano MD, Das S, Hare GMT, Mazer CD. Effect of bilateral scalp nerve blocks on postoperative pain and discharge times in patients undergoing supratentorial craniotomy and general anesthesia: a randomized-controlled trial. Can J Anaesth. 2020 Apr;67(4):452-461. doi: 10.1007/s12630-019-01558-7. Epub 2019 Dec 26. |
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| ID | Term |
|---|---|
| D015173 | Supratentorial Neoplasms |
| D000783 | Aneurysm |
| D001165 | Arteriovenous Malformations |
| D004827 | Epilepsy |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| 24 and 48 hours |
| the incidence of nausea and vomiting in the first 24 and 48 post-operative hours | 24 and 48 hours |
| the time for patients to reach discharge eligibility from the PACU/ICU | Discharge time and date from PACU/ICU |
| the time for patients to reach discharge eligibility from hospital | 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 | 5, 30 and 60 days |
| Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5 | day 5 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |