CraniotomyNCT03776617
Scalp Block in Elective Craniotomy for Tumor Dissection Trial
A study testing scalp block in people with Craniotomy, run by George Papanicolaou Hospital at 1 site in Greece.
Trial summary
This study was designed to evaluate the effect of scalp block combined with general anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients undergoing elective 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
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jan 2019to Dec 2019
- 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
- patients with American Society of Anesthesiologists Physical status classification 1-3
- patients who are scheduled for elective craniotomy for brain tumor
- patients who have provided consent for participation in the study
Who cannot join
- Patients who have allergy to local anesthetics and dexmedetomidine
- Glasgow coma scale <15
- tumor>4cm
- any contraindication for receiving dexmedetomidine
- severe mental impairment
- pregnant women
- uncontrolled hypertension, arrhythmia, coagulation disorder
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
George Papanikoalou Hospital
Thessaloniki, 57010
Chrysoula Stachtari, MD, PhD, chryssastachtari@yahoo.gr
Zoi Stergiouda, MD, zstergiouda@yahoo.gr
About this study
Official title: Regional Scalp Block With Ropivacaine 0.5% in Patients Undergoing Elective Craniotomy: a Prospective Randomized Controlled Trial
This study was designed to evaluate the effect of scalp block combined with general anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients undergoing elective craniotomy. Scalp block will be applied to three groups with differences of the administered solution to the scalp and one group will be placebo group.
Read the detailed description
Regional scalp block (RSB) is an established technique that involves infiltration of local anesthetic (LA) at well-defined anatomical sites targeting the major sensory innervation of the scalp. Regional techniques minimize anesthetic requirements and their effects may be beneficial. There is a lack of consensus and evidence concerning alternative analgesia strategies for cranial neurosurgery.
Patients undergoing elective craniotomy for tumor dissection will be randomly divided into four groups to receive scalp block as an adjuvant to general anesthesia. After a standard induction sequence using propofol, fentanyl and a single dose of rocuronium, patients will be intubated. Bilateral scalp block will be given immediately after induction, except patients in control group who will not have a scalp block. Drugs for scalp block will be 20ml ropivacaine 0.5%, 20ml xylocaine 1% and dexmedetomidine 1mcg/kg.Anaesthesia will be maintained with propofol and remifentanyl infusion. Intraoperatively, propofol infusion at 75 to 100 μg/kg/h up to dura closure and reduced to 50-75 μg/kg/h up to skin closure. Five minutes before head pinning scalp block was performed by blocking the supraorbital, supratrochlear, auriculotemporal, occipital, and postauricular branches of the greater auricular nerves.Routine monitoring of electrocardiogram, heart rate (HR), and mean arterial blood pressure (MAP) will record at two-minute intervals from the beginning of anesthesia until 10 minutes after incision, followed by 5-minute intervals throughout the remaining course of the surgery. Monitoring of the depth of anesthesia will also performed using the Bispectral Index. Sample size was calculated based on Type I error of α = 5% and power = 80% and minimum difference d = 30%, which is clinically significant in the pilot study. All quantitative variables will be reported as mean and standard deviation, and qualitative variables will be listed as number (percentage). Mann-Whitney test and Chi-square test will be used for comparison of endpoints. Linear mixed model will be used to evaluate the differences of hemodynamics variables. Statistical Package for Social Sciences (SPSS, version 19.0; SPSS Inc., Chicago, USA) will be used for all calculations. p values less than .05 will be considered significant.
- Conditions
- Craniotomy
- Being tested
- scalp block
- Keywords
- scalp block, craniotomy, dexmedetomidine, ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scalp blockProcedure or surgery
Scalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves.
| Study group | Role | What they receive |
|---|---|---|
| Group Ropivacaine | Experimental | general anesthesia + scalp block with 20 ml xylocaine 1% and 20ml ropivacaine 0.5% Receives: Procedure: scalp block |
| Group Ropivacaine-Dexmedetomidine | Experimental | general anesthesia + scalp block with 20 ml xylocaine 1%, 20ml ropivacaine 0.5% and 1mcg/kg dexmedetomidine Receives: Procedure: scalp block |
| Group control | No intervention | general anesthesia |
| Group sham | Sham comparator | general anesthesia + Scalp block with 40ml Normal Saline Receives: Procedure: scalp block |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative opioid consumption
The overall intravenous fentanyl and remifentanil consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.
Measured: intraoperative
systolic arterial pressure and diastolic arterial pressure
The systolic and diastolic blood pressure and heart rate change from baseline will be calculated. The unit for blood pressure is mmHg.
Measured: intraoperative
heart rate fluctuation
heart rate change from baseline will be calculated. The unit for heart rate is bpm
Measured: intraoperative
Secondary outcomes (1)
extubation time
Time from the end of anesthetic to fully awake and extubation
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start5 Jan 2019
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stachtari Chrysoula MD, PhD, George Papanicolaou Hospital
- Investigators
- Anastasia Trikoupi, MD, PhD, Study director, General Hospital of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776617
- Sponsor's protocol ID
- ScalCran
- Status last verified
- Dec 2018
- First submitted
- 16 May 2018
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Scalp Block With Ropivacaine 0.5% in Patients Undergoing Elective Craniotomy: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03776617
- Acronym / sponsor ID
- ScalCran
- Conditions
- Craniotomy
- Keywords
- scalp block, craniotomy, dexmedetomidine, ropivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Dec 2018 (actual)
- 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.
This study was designed to evaluate the effect of scalp block combined with general anesthesia on the intraoperative consumption of fentanyl and time of extubation of patients undergoing elective craniotomy. Scalp block will be applied to three groups with differences of the administered solution to the scalp and one group will be placebo group.
Detailed description
Regional scalp block (RSB) is an established technique that involves infiltration of local anesthetic (LA) at well-defined anatomical sites targeting the major sensory innervation of the scalp. Regional techniques minimize anesthetic requirements and their effects may be beneficial. There is a lack of consensus and evidence concerning alternative analgesia strategies for cranial neurosurgery.
Patients undergoing elective craniotomy for tumor dissection will be randomly divided into four groups to receive scalp block as an adjuvant to general anesthesia. After a standard induction sequence using propofol, fentanyl and a single dose of rocuronium, patients will be intubated. Bilateral scalp block will be given immediately after induction, except patients in control group who will not have a scalp block. Drugs for scalp block will be 20ml ropivacaine 0.5%, 20ml xylocaine 1% and dexmedetomidine 1mcg/kg.Anaesthesia will be maintained with propofol and remifentanyl infusion. Intraoperatively, propofol infusion at 75 to 100 μg/kg/h up to dura closure and reduced to 50-75 μg/kg/h up to skin closure. Five minutes before head pinning scalp block was performed by blocking the supraorbital, supratrochlear, auriculotemporal, occipital, and postauricular branches of the greater auricular nerves.Routine monitoring of electrocardiogram, heart rate (HR), and mean arterial blood pressure (MAP) will record at two-minute intervals from the beginning of anesthesia until 10 minutes after incision, followed by 5-minute intervals throughout the remaining course of the surgery. Monitoring of the depth of anesthesia will also performed using the Bispectral Index. Sample size was calculated based on Type I error of α = 5% and power = 80% and minimum difference d = 30%, which is clinically significant in the pilot study. All quantitative variables will be reported as mean and standard deviation, and qualitative variables will be listed as number (percentage). Mann-Whitney test and Chi-square test will be used for comparison of endpoints. Linear mixed model will be used to evaluate the differences of hemodynamics variables. Statistical Package for Social Sciences (SPSS, version 19.0; SPSS Inc., Chicago, USA) will be used for all calculations. p values less than .05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group Ropivacaine | Experimental | Procedure: scalp blockgeneral anesthesia + scalp block with 20 ml xylocaine 1% and 20ml ropivacaine 0.5% |
| Group Ropivacaine-Dexmedetomidine | Experimental | Procedure: scalp blockgeneral anesthesia + scalp block with 20 ml xylocaine 1%, 20ml ropivacaine 0.5% and 1mcg/kg dexmedetomidine |
| Group control | No intervention | –general anesthesia |
| Group sham | Sham comparator | Procedure: scalp blockgeneral anesthesia + Scalp block with 40ml Normal Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with American Society of Anesthesiologists Physical status classification 1-3
- patients who are scheduled for elective craniotomy for brain tumor
- patients who have provided consent for participation in the study
Key exclusion criteria (7 listed)
- Patients who have allergy to local anesthetics and dexmedetomidine
- Glasgow coma scale <15
- tumor>4cm
- any contraindication for receiving dexmedetomidine
- severe mental impairment
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 blockScalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves. | Procedure or surgery | Group Ropivacaine, Group Ropivacaine-Dexmedetomidine, Group sham |
Primary outcome
intraoperative opioid consumption
Time frame: intraoperative
The overall intravenous fentanyl and remifentanil consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.
systolic arterial pressure and diastolic arterial pressure
Time frame: intraoperative
The systolic and diastolic blood pressure and heart rate change from baseline will be calculated. The unit for blood pressure is mmHg.
heart rate fluctuation
Time frame: intraoperative
heart rate change from baseline will be calculated. The unit for heart rate is bpm
1 secondary outcome
extubation time
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- 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.
Anastasia Trikoupi, MD, PhD study director
General Hospital of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scalp block in people with Craniotomy, run by George Papanicolaou Hospital at 1 site in Greece.
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 3 inclusion and 7 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 3 Sep 2019. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chrysoula Stachtari, MD, PhD (+306946140458, chryssastachtari@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative opioid consumption (time frame: intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2019.