NCT01303107

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
Last Updated

March 26, 2014

Status Verified

January 1, 2011

First QC Date

February 23, 2011

Last Update Submit

March 25, 2014

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • duration of the anesthesia

    recovery of the sensibility

  • Degree of motor block

    End of motor block

  • maximal level of the sensitive blockade

    last level of sensitive blockade

  • Maternal cardiocirculatory and respiratory parameters

    During the study

  • Parturients ambulation

    regression of the motor blockade

  • +2 more secondary outcomes

Study Arms (2)

bupivacaine S50:R50

ACTIVE COMPARATOR

3 ml subarachnoid block

Drug: Bupivacaine

bupivacaine S75:R25

EXPERIMENTAL

3 ml for subarachnoid block

Drug: Bupivacaine

Interventions

BupivacaineDRUG

single dose of 15 mg by a slow injection rate of 1 mL/s

Also known as: Marcaine
bupivacaine S50:R50bupivacaine S75:R25

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Irmandade da Santa Casa da Misericórdia de Santos

Santos, São Paulo, Brazil

Location

Irmandade da Santa Casa de Misericóridia de São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Liga Mathias, PhD

    Irmandade da Santa Casa de Misericórdia de São Paulo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 24, 2011

Last Updated

March 26, 2014

Record last verified: 2011-01

Locations

BR(2)