Supratentorial NeoplasmsNCT00972790
Scalp Nerve Blocks for Post-Craniotomy Pain
A study testing Bilateral Scalp Nerve Blocks in people with Supratentorial Neoplasms and Aneurysms, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supratentorial Neoplasms, Aneurysms, Arteriovenous Malformation
- What is being tested?
- Bilateral Scalp Nerve Blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Bilateral Scalp Nerve Blocks
- Keywords
- brain tumor, un-ruptured aneurysm, arteriovenous malformation, epileptic focus, supratentorial
- Medical subject headings
- Supratentorial Neoplasms, Aneurysm, Arteriovenous Malformations, Epilepsy, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Scalp Nerve BlocksProcedure or surgery
Also called 0.5% Marcaine, Normal Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Bilateral Scalp Nerve Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
Measured: 24 hours
Secondary outcomes (8)
48h post-operative pooled VAS score
Measured: 48 hours
the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
Measured: 24 and 48 hours
total hydromorphone demands and delivered doses in the first 24 and 48 post-operative hours
Measured: 24 and 48 hours
the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
Measured: 24 and 48 hours
the time for patients to reach discharge eligibility from the PACU/ICU
Measured: Discharge time and date from PACU/ICU
the time for patients to reach discharge eligibility from hospital
Measured: 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
Measured: 5, 30 and 60 days
Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supratentorial NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor
- Investigators
- Andrea Rigamonti, MD, MSc (c), Principal investigator, St. Michael's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972790
- Sponsor's protocol ID
- 09-0041-GAP
- Status last verified
- Dec 2011
- First submitted
- 4 Sep 2009
- Last updated
- 1 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31879855
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bilateral Scalp Nerve Blocks on Post-operative Pain and Discharge Times in Patients Undergoing Supra-tentorial Craniotomy and General Anaesthesia
- ClinicalTrials.gov ID
- NCT00972790
- Acronym / sponsor ID
- 09-0041-GAP
- Keywords
- brain tumor, un-ruptured aneurysm, arteriovenous malformation, epileptic focus, supratentorial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Procedure: Bilateral Scalp Nerve BlocksThe 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. |
| Intervention Group | Active comparator | Procedure: Bilateral Scalp Nerve BlocksThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adults aged 18 years and over;
- patients scheduled for elective craniotomy under general anaesthesia for one of the following surgeries:
- ASA physical status < IV.
Key exclusion criteria (16 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Scalp Nerve BlocksAlso: 0.5% Marcaine, Normal SalineScalp 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. | Procedure or surgery | Control Group, Intervention Group |
Primary outcome
The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy.
Time frame: 24 hours
8 secondary outcomes
48h post-operative pooled VAS score
Time frame: 48 hours
the total PCA hydromorphone consumption in the first at 24 and 48 post-operative hours
Time frame: 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
the incidence of nausea and vomiting in the first 24 and 48 post-operative hours
Time frame: 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
the time for patients to reach discharge eligibility from hospital
Time frame: 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
Karnofsky Performance Scale Index and modified pain treatment satisfaction scale (PTSS) at day 5
Time frame: day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
- Derived from this study: PubMed 31879855Rigamonti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Rigamonti, MD, MSc (c) principal investigator
St. Michael's Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Scalp Nerve Blocks in people with Supratentorial Neoplasms and Aneurysms, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be the 24h post-operative VAS score among adults undergoing supratentorial craniotomy. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2012.