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

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).

Study Overview

• Status: Withdrawn
• Conditions: Cesarean Delivery
• Intervention / Treatment: Drug: Bupivacaine

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Irmandade da Santa Casa de Misericóridia de São Paulo
  • São Paulo
    • Santos, São Paulo, Brazil
      • Irmandade da Santa Casa da Misericórdia de Santos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
latency of sensitive block at T6	The anesthesiologist will evaluate the loss of pain to pin-prick in T10.	loss of pain in T6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of the anesthesia	Time to recover the sensibility due to the anesthetic	recovery of the sensibility
Degree of motor block	Evaluated by the Bromage scale after the injection of the anesthetic solution	End of motor block
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
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
Parturients ambulation	Will be measured the time that the parturients ambulate, due to de regression of the motor blockade	regression of the motor blockade
Visceral pain	Visceral pain will be assessed at the time of suture of the peritoneum.	suture of the peritoneum
Neonatal repercussions	Evaluation of the Apgar index in the first and fifth minutes.	birth of the neonatal

Collaborators and Investigators

• Sponsor: Cristália Produtos Químicos Farmacêuticos Ltda.
• Collaborators: 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 Misericordia de Sao Paulo

Study record dates

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 26, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: CRIST019