Brain TumourPhase 4NCT02057367
Scalp Nerve Block and Opioid Consumption in Brain Surgery
A Phase 4 study testing Scalp block with 0.5% plain Marcaine and Scalp block with 0.9% normal saline in people with Brain Tumour, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumour
- What is being tested?
- Scalp block with 0.5% plain Marcaine and Scalp block with 0.9% normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Apr 2016
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who have supratentorial brain tumor
- Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
- Patients have been general anesthetized with endotracheal intubation and control ventilation
- Patients who have provided consent for the participation in the research and for the use of their medical record in research
Who cannot join
- Pregnant patients
- Patients who have a history of local anesthetic allergy and/ or anaphylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).
Read the detailed description
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).
A Prospective Randomized Double Blind Control
- Conditions
- Brain Tumour
- Being tested
- Scalp block with 0.5% plain Marcaine, Scalp block with 0.9% normal saline
- Keywords
- supratentorial brain tumour, craniotomy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp block with 0.5% plain MarcaineDrug
Also called Code 1
Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.
Scalp block with 0.9% normal salineDrug
Also called Code 2
Anterior scalp block will be done by using 0.9% normal saline 20 ml.
| Study group | Role | What they receive |
|---|---|---|
| Scalp block with 0.5% plain marcaine | Experimental | Anterior scalp block with 0.5% plain Marcaine 20 ml. Receives: Drug: Scalp block with 0.5% plain Marcaine |
| Scalp block with 0.9% normal saline | Placebo comparator | Anterior scalp block with 0.9% normal saline 20 ml. Receives: Drug: Scalp block with 0.9% normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative opioid consumption
The overall intravenous fentanyl 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: During the supratentorial craniotomy surgery
Secondary outcomes (2)
systolic blood pressure change
The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded.
The systolic blood pressure change from baseline will be calculated. The unit is mmHg.
Measured: within 5 minutes after skull pin insertion
Heart rate change
The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded.
The heart rate change from baseline level will be calculated. The unit is beats per minute.
Measured: within 5 minutes after skull pin insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumourStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pathomporn Pin on, M.D., Chiang Mai University
- Investigators
- Pathomporn Pin-on, M.D., Principal investigator, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057367
- Sponsor's protocol ID
- ANE2556-01510
- Status last verified
- Jul 2016
- First submitted
- 26 Sep 2013
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled
- ClinicalTrials.gov ID
- NCT02057367
- Acronym / sponsor ID
- ANE2556-01510
- Conditions
- Brain Tumour
- Keywords
- supratentorial brain tumour, craniotomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Feb 2014 (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.
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).
Detailed description
Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).
A Prospective Randomized Double Blind Control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scalp block with 0.5% plain marcaine | Experimental | Drug: Scalp block with 0.5% plain MarcaineAnterior scalp block with 0.5% plain Marcaine 20 ml. |
| Scalp block with 0.9% normal saline | Placebo comparator | Drug: Scalp block with 0.9% normal salineAnterior scalp block with 0.9% normal saline 20 ml. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have supratentorial brain tumor
- Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position
- Patients have been general anesthetized with endotracheal intubation and control ventilation
- Patients who have provided consent for the participation in the research and for the use of their medical record in research
Key exclusion criteria (2 listed)
- Pregnant patients
- Patients who have a history of local anesthetic allergy and/ or anaphylaxis
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 block with 0.5% plain MarcaineAlso: Code 1Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml. | Drug | Scalp block with 0.5% plain marcaine |
| Scalp block with 0.9% normal salineAlso: Code 2Anterior scalp block will be done by using 0.9% normal saline 20 ml. | Drug | Scalp block with 0.9% normal saline |
Primary outcome
Intraoperative opioid consumption
Time frame: During the supratentorial craniotomy surgery
The overall intravenous fentanyl 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.
2 secondary outcomes
systolic blood pressure change
Time frame: within 5 minutes after skull pin insertion
Heart rate change
Time frame: within 5 minutes after skull pin insertion
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 27 Jul 2016.
- 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.
Pathomporn Pin-on, M.D. principal investigator
Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Scalp block with 0.5% plain Marcaine and Scalp block with 0.9% normal saline in people with Brain Tumour, run by Chiang Mai University at 1 site in Thailand.
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 4 inclusion and 2 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 27 Jul 2016. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intraoperative opioid consumption (time frame: During the supratentorial craniotomy surgery). 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 27 Jul 2016.