- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00972790
Scalp Nerve Blocks for Post-Craniotomy Pain
Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia
Study Overview
Status
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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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:
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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
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
48h post-operative pooled VAS score
Time Frame: 48 hours
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48 hours
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the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
Time Frame: 24 and 48 hours
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24 and 48 hours
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total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours
Time Frame: 24 and 48 hours
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24 and 48 hours
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the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
Time Frame: 24 and 48 hours
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24 and 48 hours
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the time for patients to reach discharge eligibility from the PACU/ICU
Time Frame: Discharge time and date from PACU/ICU
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Discharge time and date from PACU/ICU
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the time for patients to reach discharge eligibility from hospital
Time Frame: Discharge time and date from hospital
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Discharge time and date from hospital
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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
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5, 30 and 60 days
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Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5
Time Frame: day 5
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day 5
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrea Rigamonti, MD, MSc (c), St. Michael's Hospital, University of Toronto
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Cardiovascular Abnormalities
- Vascular Malformations
- Congenital Abnormalities
- Arteriovenous Malformations
- Aneurysm
- Supratentorial Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- 09-0041-GAP
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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