Cesarean DeliveryPhase 3NCT01303107
Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean
A Phase 3 study testing Bupivacaine in people with Cesarean Delivery, run by Cristália Produtos Químicos Farmacêuticos Ltda. at 2 sites in Brazil.
Trial summary
The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- parturients at term
- ASA (American Society of Anesthesiologists) I or ASA II
- elective cesarean section with low risk labor
- pre-natal follow-up
- patient consent
Who cannot join
- relative or absolute contraindications for spinal anesthesia
- history of hypersensitivity to the local anesthetics
- use of opioids during labor
- labor lasting more than 12 hours or less than 1 hour
- complications of pregnancy such as placenta previa, pre-eclampsia or eclampsia; maternal-fetal malnutrition;important accidents during pregnancy.
- spinal lesions, peripheral neuropathies or any other neurologic disorders that lead to changes of sensitivity and/or motricity
Show all 12Show fewer
- decompensated diabetes or hypertension
- history of alcohol and/or drug abuse
- cardiopathies, especially myocardiopathies and valvulopathies; important cognitive changes
- changes in safety exams
- twin pregnancy;
- signs of intrauterine distress, and abnormalities of fetal vitality, prematurity
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Irmandade da Santa Casa da Misericórdia de Santos
Santos, São Paulo
Irmandade da Santa Casa de Misericóridia de São Paulo
São Paulo, São Paulo
About this study
Official title: A Non-Inferiority Phase 3 Comparative Study Between a Heavy Levobupivacaine in 50% Enantiomeric Excess (Bupivacaine S75:R25) and Heavy Racemic Bupivacaine for Cesarean Operation
The purpose of this study is to determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).
Read the detailed description
The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaine and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).
- Conditions
- Cesarean Delivery
- 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 15 mg by a slow injection rate of 1 mL/s
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine S50:R50 | Active comparator | 3 ml subarachnoid block Receives: Drug: Bupivacaine |
| bupivacaine S75:R25 | Experimental | 3 ml for subarachnoid block Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
latency of sensitive block at T6
The anesthesiologist will evaluate the loss of pain to pin-prick in T10.
Measured: loss of pain in T6
Secondary outcomes (7)
duration of the anesthesia
Time to recover the sensibility due to the anesthetic
Measured: recovery of the sensibility
Degree of motor block
Evaluated by the Bromage scale after the injection of the anesthetic solution
Measured: End of motor block
maximal level of the sensitive blockade
Evaluation by pin-prick every 2 minutes after the injection of the anesthetic solution.
Measured: last level of sensitive blockade
Maternal cardiocirculatory and respiratory parameters
systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and oxygen saturation (SpO2) are evaluate during the study
Measured: During the study
Parturients ambulation
Will be measured the time that the parturients ambulate, due to de regression of the motor blockade
Measured: regression of the motor blockade
Visceral pain
Visceral pain will be assessed at the time of suture of the peritoneum.
Measured: suture of the peritoneum
Neonatal repercussions
Evaluation of the Apgar index in the first and fifth minutes.
Measured: birth of the neonatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 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 Cesarean DeliveryStudies 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, Irmandade da Santa Casa da Misericórdia de Santos
- Responsible party
- Sponsor
- Investigators
- Liga Mathias, PhD, Principal investigator, Irmandade da Santa Casa de Misericórdia de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303107
- Sponsor's protocol ID
- CRIST019
- Status last verified
- Jan 2011
- 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
- A Non-Inferiority Phase 3 Comparative Study Between a Heavy Levobupivacaine in 50% Enantiomeric Excess (Bupivacaine S75:R25) and Heavy Racemic Bupivacaine for Cesarean Operation
- ClinicalTrials.gov ID
- NCT01303107
- Acronym / sponsor ID
- CRIST019
- Conditions
- Cesarean Delivery
- 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, Irmandade da Santa Casa da Misericórdia de Santos
- First posted
- 24 Feb 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 determine if the mixture of enantiomers of bupivacaine (bupivacaine S75:R25) dos not represent inferiority efficacy and safety compare to the racemic mixture of enantiomers of bupivacaine (bupivacaine S50:R50).
Detailed description
The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaine and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).
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 S50:R50 | Active comparator | Drug: Bupivacaine3 ml subarachnoid block |
| bupivacaine S75:R25 | Experimental | Drug: Bupivacaine3 ml for subarachnoid block |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- parturients at term
- ASA (American Society of Anesthesiologists) I or ASA II
- elective cesarean section with low risk labor
- pre-natal follow-up
- patient consent
Key exclusion criteria (12 listed)
- relative or absolute contraindications for spinal anesthesia
- history of hypersensitivity to the local anesthetics
- use of opioids during labor
- labor lasting more than 12 hours or less than 1 hour
- complications of pregnancy such as placenta previa, pre-eclampsia or eclampsia; maternal-fetal malnutrition;important accidents during pregnancy.
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 15 mg by a slow injection rate of 1 mL/s | Drug | bupivacaine S50:R50, bupivacaine S75:R25 |
Primary outcome
latency of sensitive block at T6
Time frame: loss of pain in T6
The anesthesiologist will evaluate the loss of pain to pin-prick in T10.
7 secondary outcomes
duration of the anesthesia
Time frame: recovery of the sensibility
Degree of motor block
Time frame: End of motor block
maximal level of the sensitive blockade
Time frame: last level of sensitive blockade
Maternal cardiocirculatory and respiratory parameters
Time frame: During the study
Parturients ambulation
Time frame: regression of the motor blockade
Visceral pain
Time frame: suture of the peritoneum
Neonatal repercussions
Time frame: birth of the neonatal
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.
Liga 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 Cesarean Delivery, 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 5 inclusion and 12 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?
latency of sensitive block at T6 (time frame: loss of pain in T6). 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.