Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean

This study has been withdrawn prior to enrollment.
(The Sponsor has no interest in continuing the study.)
Sponsor:
Collaborators:
Irmandade da Santa Casa de Misericordia de Sao Paulo
Irmandade da Santa Casa da Misericórdia de Santos
Information provided by (Responsible Party):
Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier:
NCT01303107
First received: February 23, 2011
Last updated: March 25, 2014
Last verified: January 2011
  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 Cesarean Operation

Resource links provided by NLM:


Further study details as provided by Cristália Produtos Químicos Farmacêuticos Ltda.:

Primary Outcome Measures:
  • latency of sensitive block at T6 [ Time Frame: loss of pain in T6 ] [ Designated as safety issue: No ]
    The anesthesiologist will evaluate 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 ambulation [ Time Frame: regression of the motor blockade ] [ Designated as safety issue: No ]
    Will be measured the time that the parturients ambulate, 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.


Enrollment: 0
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% levobupivacaine 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 (American Society of Anesthesiologists) 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, 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303107

Locations
Brazil
Irmandade da Santa Casa da Misericórdia de Santos
Santos, São Paulo, Brazil
Irmandade da Santa Casa de Misericóridia de São Paulo
São Paulo, Brazil
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: Cristália Produtos Químicos Farmacêuticos Ltda.
ClinicalTrials.gov Identifier: NCT01303107     History of Changes
Other Study ID Numbers: CRIST019
Study First Received: February 23, 2011
Last Updated: March 25, 2014
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 September 22, 2014