Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarian
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Cristália Produtos Químicos Farmacêuticos Ltda..
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Cristália Produtos Químicos Farmacêuticos Ltda.
Collaborators:
Irmandade da Santa Casa de Misericordia de Sao Paulo
Irmandade da Santa Casa da Misericórdia de Santos
Information provided by:
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01303107
First received: February 23, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Cesarean Delivery |
Drug: Bupivacaine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| 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 Cesarian Operation |
Resource links provided by NLM:
Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:
Primary Outcome Measures:
- latency of sensitve block at T6 [ Time Frame: loss of pain in T6 ] [ Designated as safety issue: No ]The anesthesiologist will avaluate the loss of pain to pin-prick in T10.
Secondary Outcome Measures:
- duration of the anesthesia [ Time Frame: recovery of the sensibility ] [ Designated as safety issue: No ]Time to recover the sensibility due to the anesthetic
- Degree of motor block [ Time Frame: End of motor block ] [ Designated as safety issue: No ]Evaluated by the Bromage scale after the injection of the anesthetic solution
- maximal level of the sensitive blockade [ Time Frame: last level of sensitive blockade ] [ Designated as safety issue: No ]Evaluation by pin-prick every 2 minutes after the injection of the anesthetic solution.
- Maternal cardiocirculatory and respiratory parameters [ Time Frame: During the study ] [ Designated as safety issue: No ]systolic and diastolic blood pressure (SBP and DBP), heart rate (HR), and oxygen saturation (SpO2) are evaluate during the study
- Parturients deambulation [ Time Frame: regression of the motor blockade ] [ Designated as safety issue: No ]Will be measure the time that the parturients deambulate, due to de regression of the motor blockade
- Visceral pain [ Time Frame: suture of the peritoneum ] [ Designated as safety issue: No ]Visceral pain will be assessed at the time of suture of the peritoneum.
- Neonatal repercussions [ Time Frame: birth of the neonatal ] [ Designated as safety issue: No ]Evaluation of the Apgar index in the first and fifth minutes.
| Estimated Enrollment: | 48 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: bupivacaine S50:R50
3 mL subarachnoid block
|
Drug: Bupivacaine
single dose of 15 mg by a slow injection rate of 1 mL/s
Other Name: Marcaine
|
|
Experimental: bupivacaine S75:R25
3 mL for subarachnoid block
|
Drug: Bupivacaine
single dose of 15 mg by a slow injection rate of 1 mL/s
Other Name: Marcaine
|
Detailed Description:
The enantiomeric mixture of bupivacaine S75:R25 (75% levobupivacaíne and 25% bupivacaine) was develop to be a safety regional anesthetic in substitution to racemic bupivacaine (S50:R50).
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- parturients at term
- ASA I or ASA II
- elective cesarean section with low risk labor
- pre-natal follow-up
- patient consent
Exclusion Criteria:
- 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, preeclampsia or eclâmpsia; 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
- decompensated diabetes or hypertension
- history of alcohol and/or drug abuse
- cardiopathies, especially myocardiopathiesand valvulopathies; important cognitive changes
- changes in safety exams
- twin pregnancy;
- signs of intrauterine distress, and abnormalities of fetal vitality, prematurity
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303107
Contacts
| Contact: Ligia Mathias, PhD | rtimao@uol.com.br |
Locations
| Brazil | |
| Irmandade da Santa Casa da Misericórdia de Santos | Not yet recruiting |
| Santos, São Paulo, Brazil | |
| Contact: Celso Schmalfuss Nogueira, PhD nogueira@bignet.com.br | |
| Principal Investigator: Celso S Nogueira, PhD | |
| Irmandade da Santa Casa de Misericóridia de São Paulo | Not yet recruiting |
| São Paulo, Brazil | |
| Contact: Ligia Mathias, PhD rtimao@uol.com.br | |
| Principal Investigator: Ligia Mathias, PhD | |
Sponsors and Collaborators
Cristália Produtos Químicos Farmacêuticos Ltda.
Irmandade da Santa Casa de Misericordia de Sao Paulo
Irmandade da Santa Casa da Misericórdia de Santos
Investigators
| Principal Investigator: | Liga Mathias, PhD | Irmandade da Santa Casa de Misericórdia de São Paulo |
More Information
No publications provided
| Responsible Party: | Jorge Barros Afiune, Cristalia Produtos Quimicos Farmaceuticos Ltda |
| ClinicalTrials.gov Identifier: | NCT01303107 History of Changes |
| Other Study ID Numbers: | CRIST019 |
| Study First Received: | February 23, 2011 |
| Last Updated: | February 23, 2011 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013