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Scalp Nerve Blocks for Post-Craniotomy Pain

Primary Purpose

Supratentorial Neoplasms, Aneurysms, Arteriovenous Malformation

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bilateral Scalp Nerve Blocks
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supratentorial Neoplasms focused on measuring brain tumor, un-ruptured aneurysm, arteriovenous malformation, epileptic focus, supratentorial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Control Group

Intervention Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

48h post-operative pooled VAS score
the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours
the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
the time for patients to reach discharge eligibility from the PACU/ICU
the time for patients to reach discharge eligibility from hospital
presence of long term pain as measured with the Numeric Rating Scale (NRS) at days 5, 30 and 60 postoperatively
Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5

Full Information

First Posted
September 4, 2009
Last Updated
February 29, 2012
Sponsor
Unity Health Toronto
Collaborators
The Physicians' Services Incorporated Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00972790
Brief Title
Scalp Nerve Blocks for Post-Craniotomy Pain
Official Title
Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
Collaborators
The Physicians' Services Incorporated Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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: resection of a brain tumour clipping of an un-ruptured cerebral aneurysm excision of an artero-venous malformation (AVM), or 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Neoplasms, Aneurysms, Arteriovenous Malformation, Epilepsy
Keywords
brain tumor, un-ruptured aneurysm, arteriovenous malformation, epileptic focus, supratentorial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Sham Comparator
Arm 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.
Arm Title
Intervention Group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Scalp Nerve Blocks
Other Intervention Name(s)
0.5% Marcaine, Normal Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
48h post-operative pooled VAS score
Time Frame
48 hours
Title
the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
Time Frame
24 and 48 hours
Title
total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours
Time Frame
24 and 48 hours
Title
the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
Time Frame
24 and 48 hours
Title
the time for patients to reach discharge eligibility from the PACU/ICU
Time Frame
Discharge time and date from PACU/ICU
Title
the time for patients to reach discharge eligibility from hospital
Time Frame
Discharge time and date from hospital
Title
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
Title
Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5
Time Frame
day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Rigamonti, MD, MSc (c)
Organizational Affiliation
St. Michael's Hospital, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
31879855
Citation
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.
Results Reference
derived

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Scalp Nerve Blocks for Post-Craniotomy Pain

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