Fracture of Lower LimbPhase 3NCT01308047
Comparing Heavy Levobupivacaine With Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine.
A Phase 3 study testing Bupivacaine in people with Fracture of Lower Limb, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 2 sites in Brazil.
Trial summary
The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Fracture of Lower Limb
- What is being tested?
- Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesBrazil
- Study dates
- Start not givento not given
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiologists) I or ASA II
- Spinal Anaesthesia for lower limb surgery
- Patient Consent
Who cannot join
- relative or absolute contraindications for spinal anesthesia
- history of hypersensitivity to the local anesthetics or components
- opioids for anesthetic adjuvant
- spinal lesions, peripheral neuropathies or any other neurologic disorders that leads to changes of sensitivity
- Body mass index = or > 35
- lumbar puncture difficulty
Show all 15Show fewer
- ventricular extrasystoles
- dementia, others loss of cognitive ability
- difficulty in the spine
- spinal cord surgery
- anaphylactic reactions or Stevens-johnson Syndrome
- polytraumatism
- alcoholism abuse and use of illicit substance
- Changes in the blood test
- Others conditions judged by investigator's opinion
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Sepaco
São Paulo, São Paulo
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo
About this study
Official title: Comparative Study of Non-inferiority Between Heavy Levobupivacaine With Enantiomeric Excess of 50% (Bupivacaine S75: R25) and Heavy Racemic Bupivacaine (Bupivacaine S50: R50) in Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
Read the detailed description
The Heavy Levobupivacaine with Enantiomeric Excess of 50% was developed to be a safe local anesthetic replacing the Heavy Racemic Bupivacaine.
This study will evaluate the non-inferiority regarding efficacy and safety of spinal anesthesia in orthopedic procedures.
- Conditions
- Fracture of Lower Limb
- Being tested
- Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called marcaine
single dose of 15mg by a slow injection rate of 1 ml/s
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine S75:R25 | Experimental | 3 ml for subarachnoid block Receives: Drug: Bupivacaine |
| bupivacaine (S50:R50) | Active comparator | 3 ml subarachnoid block Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of latency for sensory block at T10 dermatome.
Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle.
Measured: +/- 40 min after injection
Secondary outcomes (8)
Sensory block duration
Verifying the duration of anesthesia from after puncture till the presence of positive sensitivity by needle stimulation region of the foot.
Measured: +/- 3 hours
Motor Block Evaluation
Motor block evaluation by Bromage Scale every five minutes after puncture till 20 minutes.
Measured: +/- 30 min
Maximum cranial dispersion verifying the largest metamer achieved.
Evaluated by needle stimulation every 2 minutes from the removal of post-puncture needle until the maximum extension time.
Measured: +/- 45 min
Evaluation of the cardiocirculatory and respiratory parameters
Systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and oxygen saturation (SpO2) are evaluate during the study to measure the safety of cardiocirculatory and respiratory parameters
Measured: +/- 8 hours
Time of regression of motor block by Bromage Scale
Will be measure the time of recovery of the motor block, the patient have to score note 4 of the Bromage Scale
Measured: +/- 9 - 10 hours
The residual analgesic effect
Will be evaluated the end of the analgesic effect of the anesthetic solution when the patient asks for pain medication.
Measured: +/- 9-10 hours
Anesthetic failure
Evaluation of the anesthetic failure (if occur)
Measured: +/- 45 min
Adverse Events
During the study will be evaluate the presence of adverse event due to the anesthetic.
Measured: +/- 8 - 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
Why it stopped: The Sponsor has no interest in continuing the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Lower LimbStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo, Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Ligia Mathias, PhD, Principal investigator, Irmandade da Santa Casa de Misericórdia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308047
- Sponsor's protocol ID
- CRIST016
- Status last verified
- Mar 2014
- First submitted
- 23 Feb 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Non-inferiority Between Heavy Levobupivacaine With Enantiomeric Excess of 50% (Bupivacaine S75: R25) and Heavy Racemic Bupivacaine (Bupivacaine S50: R50) in Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
- ClinicalTrials.gov ID
- NCT01308047
- Acronym / sponsor ID
- CRIST016
- Conditions
- Fracture of Lower Limb
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The Sponsor has no interest in continuing the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Irmandade da Santa Casa de Misericordia de Sao Paulo, Serviço Social da Indústria do Papel, Papelão e Cortiça do Estado de São Paulo
- First posted
- 3 Mar 2011 (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.
The purpose of this study is to compare the non-inferiority between Heavy Levobupivacaine with Enantiomeric Excess of 50% and Heavy Racemic Bupivacaine During Spinal Anesthesia for Orthopedic Procedures in the Lower Limbs.
Detailed description
The Heavy Levobupivacaine with Enantiomeric Excess of 50% was developed to be a safe local anesthetic replacing the Heavy Racemic Bupivacaine.
This study will evaluate the non-inferiority regarding efficacy and safety of spinal anesthesia in orthopedic procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine S75:R25 | Experimental | Drug: Bupivacaine3 ml for subarachnoid block |
| bupivacaine (S50:R50) | Active comparator | Drug: Bupivacaine3 ml subarachnoid block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists) I or ASA II
- Spinal Anaesthesia for lower limb surgery
- Patient Consent
Key exclusion criteria (15 listed)
- relative or absolute contraindications for spinal anesthesia
- history of hypersensitivity to the local anesthetics or components
- opioids for anesthetic adjuvant
- spinal lesions, peripheral neuropathies or any other neurologic disorders that leads to changes of sensitivity
- Body mass index = or > 35
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 |
|---|---|---|
| BupivacaineAlso: marcainesingle dose of 15mg by a slow injection rate of 1 ml/s | Drug | bupivacaine (S50:R50), bupivacaine S75:R25 |
Primary outcome
Time of latency for sensory block at T10 dermatome.
Time frame: +/- 40 min after injection
Evaluate the sensory block at T10 after the anesthetic injection through sensory stimulation by needle.
8 secondary outcomes
Sensory block duration
Time frame: +/- 3 hours
Motor Block Evaluation
Time frame: +/- 30 min
Maximum cranial dispersion verifying the largest metamer achieved.
Time frame: +/- 45 min
Evaluation of the cardiocirculatory and respiratory parameters
Time frame: +/- 8 hours
Time of regression of motor block by Bromage Scale
Time frame: +/- 9 - 10 hours
The residual analgesic effect
Time frame: +/- 9-10 hours
Anesthetic failure
Time frame: +/- 45 min
Adverse Events
Time frame: +/- 8 - 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
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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.
Ligia Mathias, PhD principal investigator
Irmandade da Santa Casa de Misericórdia de São Paulo
2 sites 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 in people with Fracture of Lower Limb, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 2 sites 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 3 inclusion and 15 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: withdrawn, as of the sponsor's last update on 26 Mar 2014. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time of latency for sensory block at T10 dermatome. (time frame: +/- 40 min after injection). 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 26 Mar 2014.