Scalp Nerve Blocks for Post-Craniotomy Pain

February 29, 2012 updated by: Unity Health Toronto

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

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.

Study Overview

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:

    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).

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control Group
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.
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.
Other Names:
  • Normal Saline
  • 0.5% Marcaine
Active Comparator: Intervention 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.
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.
Other Names:
  • Normal Saline
  • 0.5% Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
48h post-operative pooled VAS score
Time Frame: 48 hours
48 hours
the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
Time Frame: 24 and 48 hours
24 and 48 hours
total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours
Time Frame: 24 and 48 hours
24 and 48 hours
the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
Time Frame: 24 and 48 hours
24 and 48 hours
the time for patients to reach discharge eligibility from the PACU/ICU
Time Frame: Discharge time and date from PACU/ICU
Discharge time and date from PACU/ICU
the time for patients to reach discharge eligibility from hospital
Time Frame: Discharge time and date 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
Time Frame: 5, 30 and 60 days
5, 30 and 60 days
Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5
Time Frame: day 5
day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea Rigamonti, MD, MSc (c), St. Michael's Hospital, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 4, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

March 1, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

December 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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