Scalp Nerve Blocks for Post-Craniotomy Pain

NCT00972790 | Completed

• 1 other identifier: 09-0041-GAP
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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, and the time required for post-anaesthesia care unit (PACU)/Intensive Care Unit (ICU) and hospital discharge.

Conditions

Supratentorial Neoplasms; Aneurysms; Arteriovenous Malformation; Epilepsy

Keywords

brain tumor; un-ruptured aneurysm; arteriovenous malformation; epileptic focus; supratentorial

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Secondary Outcomes (8)

• 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

  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

Study Arms (2)

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.

Procedure: Bilateral Scalp Nerve Blocks

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.

Procedure: Bilateral Scalp Nerve Blocks

Interventions

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.

Also known as: 0.5% Marcaine, Normal Saline

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Unity Health Toronto: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• 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.

  PMID: 31879855 DERIVED

MeSH Terms

Conditions

Supratentorial Neoplasms; Aneurysm; Arteriovenous Malformations; Epilepsy; Brain Neoplasms

Interventions

Bupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrea Rigamonti, MD, MSc (c)

  St. Michael's Hospital, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2009
• First Posted: September 9, 2009
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 1, 2012

Record last verified: 2011-12

Locations

CA (1)