Clinical trial · Interventional
Scalp Nerve Blocks for Post-Craniotomy Pain
Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia
NCT00972790CI-TRIAL-00006357completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aneurysms | — | UNRESOLVED | — |
| Arteriovenous Malformation | — | UNRESOLVED | — |
| Epilepsy | — | UNRESOLVED | — |
| Supratentorial Neoplasms | Supratentorial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bilateral Scalp Nerve Blocks | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Control Group
- description
- 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.
- interventionNames
- Procedure: Bilateral Scalp Nerve Blocks
- type
- ACTIVE_COMPARATOR
- label
- Intervention Group
- description
- 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.
- interventionNames
- Procedure: Bilateral Scalp Nerve Blocks
Primary outcomes (1)
- measure
- The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (1)
- DERIVEDRigamonti 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. PMID 31879855