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Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia

18 Years
Not Enrolling
Supratentorial Neoplasms, Aneurysms, Arteriovenous Malformation, Epilepsy

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Trial Information

Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia

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).

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

- 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

- previous craniotomy or cranial irradiation;

- history of malignant hyperthermia, which would contraindicate the anaesthesia
maintenance protocol of this study;

- pregnancy.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.

Outcome Time Frame:

24 hours

Safety Issue:


Principal Investigator

Andrea Rigamonti, MD, MSc (c)

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Michael's Hospital, University of Toronto


Canada: Ministry of Health & Long Term Care, Ontario

Study ID:




Start Date:

March 2010

Completion Date:

December 2011

Related Keywords:

  • Supratentorial Neoplasms
  • Aneurysms
  • Arteriovenous Malformation
  • Epilepsy
  • brain tumor
  • un-ruptured aneurysm
  • arteriovenous malformation
  • epileptic focus
  • supratentorial
  • Congenital Abnormalities
  • Aneurysm
  • Arteriovenous Malformations
  • Hemangioma
  • Neoplasms
  • Epilepsy
  • Supratentorial Neoplasms