Spinal AnesthesiaPhase 3NCT03883763
Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery
A Phase 3 study testing bupivacaine S75:R25 plus 8% glucose and bupivacaine S50:R50 plus 8% glucose in people with Spinal Anesthesia and Vascular Surgery, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
Trial summary
This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Anesthesia, Vascular Surgery
- What is being tested?
- bupivacaine S75:R25 plus 8% glucose and bupivacaine S50:R50 plus 8% glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2022to 30 Nov 2023
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Both sexes
- Age between 18 and 80 years, inclusive
- ASA category I or II
- Indication of spinal anesthesia for varicose vein surgery in lower limbs with a maximum duration of 3 hours.
Who cannot join
- Contraindications to spinal anesthesia
- Hypersensitivity or intolerance to local anesthetics or to the components of formula
- Use of any anticoagulant, regardless of type until 60 days before entering the study
- Spinal cord injuries, peripheral neuropathies or any other neurological conditions leading to sensory and / or motor disorders
- Dementia, mental retardation and other major cognitive changes
- Obesity with body mass index (BMI) > 30 or difficulty in performing the puncture
Show all 21Show fewer
- Anatomical difficulty in the spine in the opinion of the Investigator that can make puncture difficult
- Any previous surgical intervention of the spine
- Tattoo at the puncture site
- Participants with a history of alcohol or illicit drug abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition
- Pernicious anemia
- History of severe anaphylactic reactions or Steven-Johnson disease
- Changes in safety exams (applicable at the time of randomization):
- International Normalized Ratio ≥ 1.4
- Hemoglobin < 10 g / dL
- Platelet count <100,000 / mm3
- Glycemia> 200 mg / dL
- Bradyarrhythmias: heart block with clinical repercussion in the investigator's opinion
- Maximum of eight ventricular extrasystoles per minute, evident on the ECG
- Pregnancy or lactation
- Any other condition that, in the opinion of the Investigator, may lead to an increased risk for the participant.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
CEPEC
São Luís, Maranhão, 65020-600
Joilma Tobias, Nurse, 55 98 2109-1293, joilma.tobias@huufma.br
Renata Assis, Pharmacy, 55 98 2109-1294, renata.assis@huufma.br
About this study
Official title: Non-inferiority Study of Hyperbaric Novabupi® (Bupivacaine S75: R25) Compared to Hyperbaric Neocaine® (Bupivacaine S50: R50) in Spinal Anesthesia in Lower Limbs Vascular Surgery
This is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.
The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).
- Conditions
- Spinal Anesthesia, Vascular Surgery
- Being tested
- bupivacaine S75:R25 plus 8% glucose, bupivacaine S50:R50 plus 8% glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine S75:R25 plus 8% glucoseDrug
Spinal anesthesia, 20 mg
bupivacaine S50:R50 plus 8% glucoseDrug
Spinal anesthesia, 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Novabupi® 0.5% (bupivacaine S75:R25 + 8% glucose) | Experimental | Not described Receives: Drug: bupivacaine S75:R25 plus 8% glucose |
| Hyperbaric Neocaine® 0.5% (bupivacaine S50:R50 + 8% glucose) | Active comparator | Not described Receives: Drug: bupivacaine S50:R50 plus 8% glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between arms from latency to T10 dermatome sensitive block
Time elapsed between the withdrawal of the needle at the end of the injection of the local anesthetic and the absence of response to sensorial stimuli in the region corresponding to the T10 dermatome
Measured: 20 minutes
Comparison between arms from the duration of the sensory block
Time elapsed between the withdrawal of the needle at the end of the local anesthetic injection and the presence of positive sensitivity by needle stimulation in the L5 dermatome
Measured: 24 hours
Secondary outcomes (10)
Comparison between arms from the degree of motor blockage when blocking T10 sensitive
The motor block will be evaluated by the modified Bromage scale. The degree of motor block will be assessed when the sensory block reaches T10.
The motor block will be evaluated every 5 minutes from the end of the anesthetic injection (time 0) through the modified Bromage scale:
- 0 = without motor block,
- 1 = blocked hip,
- 2 = blocked hip and knee,
- 3 = blocked hip, knee and ankle.
Will be recorded:
- the degree of motor blockage when the sensory block reaches T10,
- the time to reach the maximum block,
- time for full recovery (Bromage score 0).
Measured: 20 minutes
Comparison between arms from the duration of the motor block
Duration of motor block will be considered as the time interval between needle withdrawal after puncture and return to score 0 on the modified Bromage scale. Time will be recorded to reach grade 3 motor block and at the end of surgery. During anesthesia recovery, evaluations will be performed every 15 minutes
Measured: 24 hours
Comparison between arms from the highest level of sensory block
Measured: 3 hours
Comparison between arms from the time to reach the highest level of sensory block
Measured: 1 hour
Comparison between arms from the time for the 4-segment regression of the sensory block
The height of the sensitive block will be evaluated every 5 minutes until the maximum level is reached. From this point, the height of the block will be evaluated every 10 minutes until the regression of 4 levels
Measured: 3 hours
Comparison between arms of respiratory and cardiovascular safety
Evidenced by the incidence, severity and causality of clinically significant SpO2 changes.
Every 5 minutes SpO2 will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until 12 hours.
Measured: 12 hours
Comparison between arms of cardiovascular safety
Evidenced by the incidence, severity and causality of clinically significant changes in blood pressure measured automatically by cardiac monitoring.
Every 5 minutes blood pressure will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until completing 180 minutes and every 30 minutes until complete recovery of the motor function.
Measured: 24 hours
Comparison between arms of cardiovascular safety
Evidenced by the incidence, severity and causality of clinically significant changes in heart rate measured automatically by cardiac monitoring.
Every 5 minutes heart rate will be recorded until completing 60 minutes, every 10 minutes until completing 120 minutes, every 20 minutes until completing 180 minutes and every 30 minutes until complete recovery of the motor function
Measured: 12 hours
Comparison between arms from the percentage of motor and sensory block failure
After the needle has been withdrawn, the anesthetic should be installed for up to 20 minutes. If no sensory and / or motor blockage is observed after this period, the Investigator will indicate that there was an anesthetic failure that should be classified as:
- total block failure (absence of anesthesia in sensory and motor aspects with preserved sensitivity of the perineal region) B. partial failure (when any area below the T10 dermatome shows signs of analgesia or motor block, but surgery can not be performed, requiring intense sedation or general anesthesia).
In case of failure, the participant will be immediately discontinued from the study and the surgery will normally proceed with anesthetic procedure at the discretion of the Investigator. Anesthesia failure should be reported as an adverse event.
Measured: 20 minutes
Comparison between arms from the occurrence of adverse events
Adverse event information will be collected from all participants on all visits
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start1 Apr 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- João B Garcia, MD/PhD, Principal investigator, HUUFMA - Hospital Universitário da Universidade Federal do Maranhão
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883763
- Sponsor's protocol ID
- CRT090
- Status last verified
- Jul 2022
- First submitted
- 11 Mar 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of Hyperbaric Novabupi® (Bupivacaine S75: R25) Compared to Hyperbaric Neocaine® (Bupivacaine S50: R50) in Spinal Anesthesia in Lower Limbs Vascular Surgery
- ClinicalTrials.gov ID
- NCT03883763
- Acronym / sponsor ID
- CRT090
- Conditions
- Spinal Anesthesia, Vascular Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 21 Mar 2019 (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 is a multicenter, randomized, double-blind, active-controlled study to evaluate the non-inferiority of hyperbaric Novabupi® versus hyperbaric Neocaine® in spinal anesthesia in lower limbs vascular surgery.
The schedule consists of four visits: screening (visit 1); pre-anesthetic evaluation and randomization (visit 2); treatment (visit 3) and discharge from study (visit 4).
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 |
|---|---|---|
| Hyperbaric Novabupi® 0.5% (bupivacaine S75:R25 + 8% glucose) | Experimental | Drug: bupivacaine S75:R25 plus 8% glucose |
| Hyperbaric Neocaine® 0.5% (bupivacaine S50:R50 + 8% glucose) | Active comparator | Drug: bupivacaine S50:R50 plus 8% glucose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of written informed consent
- Both sexes
- Age between 18 and 80 years, inclusive
- ASA category I or II
- Indication of spinal anesthesia for varicose vein surgery in lower limbs with a maximum duration of 3 hours.
Key exclusion criteria (21 listed)
- Contraindications to spinal anesthesia
- Hypersensitivity or intolerance to local anesthetics or to the components of formula
- Use of any anticoagulant, regardless of type until 60 days before entering the study
- Spinal cord injuries, peripheral neuropathies or any other neurological conditions leading to sensory and / or motor disorders
- Dementia, mental retardation and other major cognitive changes
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 |
|---|---|---|
| bupivacaine S75:R25 plus 8% glucoseSpinal anesthesia, 20 mg | Drug | Hyperbaric Novabupi® 0.5% (bupivacaine S75:R25 + 8% glucose) |
| bupivacaine S50:R50 plus 8% glucoseSpinal anesthesia, 20 mg | Drug | Hyperbaric Neocaine® 0.5% (bupivacaine S50:R50 + 8% glucose) |
Primary outcome
Comparison between arms from latency to T10 dermatome sensitive block
Time frame: 20 minutes
Time elapsed between the withdrawal of the needle at the end of the injection of the local anesthetic and the absence of response to sensorial stimuli in the region corresponding to the T10 dermatome
Comparison between arms from the duration of the sensory block
Time frame: 24 hours
Time elapsed between the withdrawal of the needle at the end of the local anesthetic injection and the presence of positive sensitivity by needle stimulation in the L5 dermatome
10 secondary outcomes
Comparison between arms from the degree of motor blockage when blocking T10 sensitive
Time frame: 20 minutes
Comparison between arms from the duration of the motor block
Time frame: 24 hours
Comparison between arms from the highest level of sensory block
Time frame: 3 hours
Comparison between arms from the time to reach the highest level of sensory block
Time frame: 1 hour
Comparison between arms from the time for the 4-segment regression of the sensory block
Time frame: 3 hours
Comparison between arms of respiratory and cardiovascular safety
Time frame: 12 hours
Comparison between arms of cardiovascular safety
Time frame: 24 hours
Comparison between arms of cardiovascular safety
Time frame: 12 hours
Comparison between arms from the percentage of motor and sensory block failure
Time frame: 20 minutes
Comparison between arms from the occurrence of adverse events
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
João B Garcia, MD/PhD principal investigator
HUUFMA - Hospital Universitário da Universidade Federal do Maranhão
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bupivacaine S75:R25 plus 8% glucose and bupivacaine S50:R50 plus 8% glucose in people with Spinal Anesthesia and Vascular Surgery, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 1 site in Brazil.
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 5 inclusion and 21 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 8 Feb 2023. 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 Brazil. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 João B Garcia, MD/PhD (+559888020622, jbgarcia@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between arms from latency to T10 dermatome sensitive block (time frame: 20 minutes). The study lists 2 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 8 Feb 2023.