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

Cesarean Delivery Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01303107
• Other study ID #: CRIST019
• Status: Withdrawn
• Phase: Phase 3
• First received: February 23, 2011
• Last updated: March 25, 2014

Study information

• Verified date: January 2011
• Source: Cristália Produtos Químicos Farmacêuticos Ltda.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

Drug:
• Bupivacaine
single dose of 15 mg by a slow injection rate of 1 mL/s

Locations

Country	Name	City	State
Brazil	Irmandade da Santa Casa da Misericórdia de Santos	Santos	São Paulo
Brazil	Irmandade da Santa Casa de Misericóridia de São Paulo	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Cristália Produtos Químicos Farmacêuticos Ltda.	Irmandade da Santa Casa da Misericórdia de Santos, Irmandade da Santa Casa de Misericordia de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	latency of sensitive block at T6	The anesthesiologist will evaluate the loss of pain to pin-prick in T10.	loss of pain in T6	No
Secondary	duration of the anesthesia	Time to recover the sensibility due to the anesthetic	recovery of the sensibility	No
Secondary	Degree of motor block	Evaluated by the Bromage scale after the injection of the anesthetic solution	End of motor block	No
Secondary	maximal level of the sensitive blockade	Evaluation by pin-prick every 2 minutes after the injection of the anesthetic solution.	last level of sensitive blockade	No
Secondary	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	During the study	No
Secondary	Parturients ambulation	Will be measured the time that the parturients ambulate, due to de regression of the motor blockade	regression of the motor blockade	No
Secondary	Visceral pain	Visceral pain will be assessed at the time of suture of the peritoneum.	suture of the peritoneum	No
Secondary	Neonatal repercussions	Evaluation of the Apgar index in the first and fifth minutes.	birth of the neonatal	No