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
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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