Scalp Nerve Blocks for Post-Craniotomy Pain

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00972790
First received: September 4, 2009
Last updated: February 29, 2012
Last verified: December 2011
  Purpose

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.


Condition Intervention
Supratentorial Neoplasms
Aneurysms
Arteriovenous Malformation
Epilepsy
Procedure: Bilateral Scalp Nerve Blocks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 48h post-operative pooled VAS score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
  • total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
  • the incidence of nausea and vomiting in the first 24 and 48 post-operative hours [ Time Frame: 24 and 48 hours ] [ Designated as safety issue: No ]
  • the time for patients to reach discharge eligibility from the PACU/ICU [ Time Frame: Discharge time and date from PACU/ICU ] [ Designated as safety issue: No ]
  • the time for patients to reach discharge eligibility from hospital [ Time Frame: Discharge time and date from hospital ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5 [ Time Frame: day 5 ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Bilateral Scalp Nerve Blocks
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:
  • 0.5% Marcaine
  • Normal Saline
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.
Procedure: Bilateral Scalp Nerve Blocks
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:
  • 0.5% Marcaine
  • Normal Saline

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972790

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Andrea Rigamonti, MD, MSc (c) St. Michael's Hospital, University of Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00972790     History of Changes
Other Study ID Numbers: 09-0041-GAP
Study First Received: September 4, 2009
Last Updated: February 29, 2012
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by St. Michael's Hospital, Toronto:
brain tumor
un-ruptured aneurysm
arteriovenous malformation
epileptic focus
supratentorial

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Aneurysm
Hemangioma
Neoplasms
Epilepsy
Supratentorial Neoplasms
Vascular Diseases
Cardiovascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 21, 2014