Supratentorial NeoplasmsNCT04344132
Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
A study testing Scalp Block in people with Supratentorial Neoplasms, run by University of Roma La Sapienza.
Trial summary
Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supratentorial Neoplasms
- What is being tested?
- Scalp Block
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2020to 30 Dec 2020
- 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
- Adult patients (>18 years),
- presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia
Who cannot join
- history of allergic reactions on local anesthetics;
- ASA status ≥ 3;
- depressed consciousness in pre- or postoperative period;
- aphasia (as investigators were not able to obtain VAS score).
About this study
Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.
- Conditions
- Supratentorial Neoplasms
- Being tested
- Scalp Block
- Medical subject headings
- Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp BlockProcedure or surgery
standard practice of controll the pain after surgery. Block of the nerve emergences.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale score at 24 h after surgery
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),
Measured: up to 24 hours
Secondary outcomes (9)
Visual Analogue Scale score at 0
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: Baseline
Visual Analogue Scale score at 2 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: up to 2 hours
Visual Analogue Scale score at 6 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: up to 6 hours
Visual Analogue Scale score at 12 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: up to 12 hours
time first request of a patient for rescue analgesia
Measured: during surgery
intraoperative anesthetics
(and opioids consumption)
Measured: during surgery time
awakening time
Measured: time from the end of surgery to awekening
changes in hemodynamics at mayfiled headfraom positioning
changes in term of blood pressure
Measured: surgery
changes in hemodynamics at mayfiled headfraom positioning
changes in heart rate
Measured: surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Supratentorial NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Bilotta, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344132
- Sponsor's protocol ID
- URom
- Status last verified
- Apr 2020
- First submitted
- 30 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bebawy JF, Bilotta F, Koht A. A modified technique for auriculotemporal nerve blockade when performing selective scalp nerve block for craniotomy. J Neurosurg Anesthesiol. 2014 Jul;26(3):271-2. doi: 10.1097/ANA.0000000000000032. No abstract available.
PubMed 24492515Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
PubMed 27996204
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
- ClinicalTrials.gov ID
- NCT04344132
- Acronym / sponsor ID
- URom
- Conditions
- Supratentorial Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 14 Apr 2020 (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.
Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years),
- presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia
Key exclusion criteria (4 listed)
- history of allergic reactions on local anesthetics;
- ASA status ≥ 3;
- depressed consciousness in pre- or postoperative period;
- aphasia (as investigators were not able to obtain VAS score).
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 Blockstandard practice of controll the pain after surgery. Block of the nerve emergences. | Procedure or surgery | – |
Primary outcome
Visual Analogue Scale score at 24 h after surgery
Time frame: up to 24 hours
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),
9 secondary outcomes
Visual Analogue Scale score at 0
Time frame: Baseline
Visual Analogue Scale score at 2 hours
Time frame: up to 2 hours
Visual Analogue Scale score at 6 hours
Time frame: up to 6 hours
Visual Analogue Scale score at 12 hours
Time frame: up to 12 hours
time first request of a patient for rescue analgesia
Time frame: during surgery
intraoperative anesthetics
Time frame: during surgery time
awakening time
Time frame: time from the end of surgery to awekening
changes in hemodynamics at mayfiled headfraom positioning
Time frame: surgery
changes in hemodynamics at mayfiled headfraom positioning
Time frame: surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Background: PubMed 24492515Bebawy JF, Bilotta F, Koht A. A modified technique for auriculotemporal nerve blockade when performing selective scalp nerve block for craniotomy. J Neurosurg Anesthesiol. 2014 Jul;26(3):271-2. doi: 10.1097/ANA.0000000000000032. No abstract available.
- Background: PubMed 27996204Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
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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 Supratentorial Neoplasms, run by University of Roma La Sapienza.
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 2 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 15 Apr 2020. 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. 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?
Visual Analogue Scale score at 24 h after surgery (time frame: up to 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 NCT04344132, which also lists 2 linked publications.
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 15 Apr 2020.