CraniotomyNCT02880566
Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy
A study testing Scalp block in people with Craniotomy, run by University of Liege.
Trial summary
Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Craniotomy
- What is being tested?
- Scalp block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- 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
- Elective craniotomy for supratentorial lesion
Who cannot join
- Allergy to local anaesthetic
- Psychiatric disease
- Inability to consent
- Uncontrolled intracranial hypertension
About this study
Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.
- Conditions
- Craniotomy
- Being tested
- Scalp block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp blockProcedure or surgery
Full scalp block
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Full scalp block performed with a total of 30 ml of levobupivacaine 0.33 %. Receives: Procedure: Scalp block |
| Control | Placebo comparator | Full scalp block performed with a total of 30 ml of normal saline. Receives: Procedure: Scalp block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic stability
Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning
Measured: 5 minutes
Secondary outcomes (3)
Cumulative intraoperative remifentanil consumption
Measured: 24 hours
Cumulative postoperative morphine consumption
Measured: 48 hours
Postoperative pain scores
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
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 CraniotomyStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880566
- Sponsor's protocol ID
- anesneuro2016001
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.
PubMed 33060491
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy
- ClinicalTrials.gov ID
- NCT02880566
- Acronym / sponsor ID
- anesneuro2016001
- Conditions
- Craniotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 26 Aug 2016 (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.
Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.
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 |
|---|---|---|
| Treatment | Experimental | Procedure: Scalp blockFull scalp block performed with a total of 30 ml of levobupivacaine 0.33 %. |
| Control | Placebo comparator | Procedure: Scalp blockFull scalp block performed with a total of 30 ml of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective craniotomy for supratentorial lesion
Key exclusion criteria (4 listed)
- Allergy to local anaesthetic
- Psychiatric disease
- Inability to consent
- Uncontrolled intracranial hypertension
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 |
|---|---|---|
| Scalp blockFull scalp block | Procedure or surgery | Control, Treatment |
Primary outcome
Hemodynamic stability
Time frame: 5 minutes
Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning
3 secondary outcomes
Cumulative intraoperative remifentanil consumption
Time frame: 24 hours
Cumulative postoperative morphine consumption
Time frame: 48 hours
Postoperative pain scores
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Derived from this study: PubMed 33060491Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp block in people with Craniotomy, run by University of Liege.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Hemodynamic stability (time frame: 5 minutes). 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 NCT02880566, 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 26 Aug 2016.