Brain TumorPhase 4NCT02558569
The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
A Phase 4 study testing Levobupivacaine and NSS in people with Brain Tumor, run by Mahidol University at 2 sites in Thailand.
Trial summary
This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor patients. The control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive scalp nerve block with 0.5% levobupivacaine (local anesthetic) and also… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Levobupivacaine and NSS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesThailand
- Study dates
- Sep 2015to Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- supratentorial brain tumor
Who cannot join
- tumor size>4 cm
- Glasgow Coma Score (GCS) <15
- already intubated
- uncontrolled hypertension
- can not communicate
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Manee Raksakietisak
Bangkok, 10700
Siriraj Hospital Mahidol University
Bangkok, 10700
About this study
Official title: The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial
This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor patients. The control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive scalp nerve block with 0.5% levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general anesthesia.
Read the detailed description
Fentanyl has widely been used for intraoperative analgesia for craniotomy. In craniotomy, the long and complex operation, the continuous infusion or repeated use of fentanyl can significantly delay emergence from general anesthesia. The scalp block with local anesthesia is widely used for awake craniotomy with great success but it is not routinely used in general craniotomy. In this study, the control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive the addition of scalp nerve block with 0.5% levobupivacaine (local anesthetic). The scalp nerve block might reduce the total dose of fentanyl and promote faster emergence from general anesthesia.
- Conditions
- Brain Tumor
- Being tested
- Levobupivacaine, NSS
- Keywords
- fentanyl, scalp block
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine
L form of bupivacaine with less cardiotoxicity.
NSSOther
Also called 0.9% NaCl or Normal saline
Clear intravenous fluid looks alike local anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine | Experimental | Scalp nerve block with 0.5% Levobupivacaine adds up to intravenous fentanyl for intraoperative pain control during supratentorial craniotomy with brain tumor removal. The scalp block includes 4-6 nerves which give sensory supply to related location with the use of total 10-15 ml of 0.5% Levobupivacaine. Intravenous fentanyl is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given. is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given. Receives: Drug: Levobupivacaine |
| NSS | Sham comparator | Scalp nerve block with 10-15 ml of 0.9% sodium chloride(NaCl), or normal saline (NSS) includes 4-6 nerves which give sensory supply to related location (sham block). Intravenous fentanyl is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given. Receives: Other: NSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total dose of fentanyl being used during craniotomy
Total dose of fentanyl use during operative period
Measured: One day
Secondary outcomes (1)
Awakening time from general anesthesia
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 posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manee Raksakietisak, Mahidol University
- Investigators
- Manee Raksakietisak, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558569
- Sponsor's protocol ID
- 359/2558(EC3
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2015
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02558569
- Acronym / sponsor ID
- 359/2558(EC3
- Conditions
- Brain Tumor
- Keywords
- fentanyl, scalp block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Sep 2015 (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.
This study evaluates the use of fentanyl during craniotomy in two groups of brain tumor patients. The control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive scalp nerve block with 0.5% levobupivacaine (local anesthetic) and also fentanyl for intraoperative pain control. The scalp nerve block might reduce the dose of fentanyl and promote faster emergence from general anesthesia.
Detailed description
Fentanyl has widely been used for intraoperative analgesia for craniotomy. In craniotomy, the long and complex operation, the continuous infusion or repeated use of fentanyl can significantly delay emergence from general anesthesia. The scalp block with local anesthesia is widely used for awake craniotomy with great success but it is not routinely used in general craniotomy. In this study, the control group will receive standard general anesthesia with the use of fentanyl for intraoperative pain control and the study group will receive the addition of scalp nerve block with 0.5% levobupivacaine (local anesthetic). The scalp nerve block might reduce the total dose of fentanyl and promote faster emergence from general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine | Experimental | Drug: LevobupivacaineScalp nerve block with 0.5% Levobupivacaine adds up to intravenous fentanyl for intraoperative pain control during supratentorial craniotomy with brain tumor removal. The scalp block includes 4-6 nerves which give sensory supply to related location with the use of total 10-15 ml of 0.5% Levobupivacaine. Intravenous fentanyl is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given. is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given. |
| NSS | Sham comparator | Other: NSSScalp nerve block with 10-15 ml of 0.9% sodium chloride(NaCl), or normal saline (NSS) includes 4-6 nerves which give sensory supply to related location (sham block). Intravenous fentanyl is used for intraoperative analgesia in both groups with continuous infusion (1 mcg/kg/hr until opening of dura and then 0.5 mcg/kg/hr until finishing of dural closure) and increment doses (0.5 mcg/kg) also given. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- supratentorial brain tumor
Key exclusion criteria (5 listed)
- tumor size>4 cm
- Glasgow Coma Score (GCS) <15
- already intubated
- uncontrolled hypertension
- can not communicate
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 |
|---|---|---|
| LevobupivacaineAlso: ChirocaineL form of bupivacaine with less cardiotoxicity. | Drug | Levobupivacaine |
| NSSAlso: 0.9% NaCl or Normal salineClear intravenous fluid looks alike local anesthetic. | Other | NSS |
Primary outcome
The total dose of fentanyl being used during craniotomy
Time frame: One day
Total dose of fentanyl use during operative period
1 secondary outcome
Awakening time from general anesthesia
Time frame: One day
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 14 Sep 2016.
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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.
Manee Raksakietisak, MD principal investigator
Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine and NSS in people with Brain Tumor, run by Mahidol University at 2 sites 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 1 inclusion and 5 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The total dose of fentanyl being used during craniotomy (time frame: One day). 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 14 Sep 2016.