Determination of the Effective Volume of 0.125% Bupivacaine-fentanyl 5mcg/mL in Labour Epidurals

NCT01972269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-06-04

No results posted yet for this study

Summary

Different medications can be used as analgesics in labor epidurals. Bupivacaine is one of the most commonly used drugs for that purpose. The efficacy of a certain medication injected epidurally depends on the dose that is given. A certain dose can be administered in different concentrations, which will consequently mean different volumes. Studies have been done to determine volumes for different concentrations of bupivacaine. However, those studies fall short in the sense that this information cannot be readily applicable in clinical practice, as we don't use bupivacaine plain. The combination of bupivacaine and fentanyl or sufentanil is common practice, as it is well established that the opioids will reduce the concentration of local anesthetic required to produce optimal effect with the least side effects.

This study is being planned to determine and compare the EV90 of the bupivacaine 0.125%-fentanyl mixture for initiation of labor epidural analgesia, following the administration of the 2 different test doses (3cc of lidocaine 2% or 3cc of the bupivacaine 0.125%-fentanyl mixture) used in our Department.

Conditions

Interventions

DRUG

Bupivacaine-fentanyl

0.125% bupivacaine-fentanyl 5mcg/mL

DRUG

Lidocaine

2% lidocaine

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Jose CA Carvalho, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01972269 on ClinicalTrials.gov