Minimum Local Anesthetic Volume of Bupivacaine in Labour Epidurals
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Determination of the Minimum Local Anesthetic Volume of 0.125% Bupivacaine in Labour Epidurals|
- Verbal Numeric Rating Scale (VNRS) less than or equal to 2 out of 10 during contraction [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||August 2007|
0.125% bupivacaine in a volume determined according to the biased coin up-down sequential allocation model, starting at 8mL.
Epidural administration of local anesthetics during labor produces analgesia, sympathetic block and motor block. The characteristics of the block depend on the volume and concentration of the local anesthetic that is used as well as the potential use of adjuncts. Although many researchers have investigated the efficacy of different drugs at different concentrations, the volumes used have been arbitrary. There is limited data regarding the minimum volume that is necessary for a successful anesthetic for a given concentration of bupivacaine.
This study is conducted as a prospective, randomized, up-down sequential allocation trial. The aim is to determine the minimum volume of 0.125% bupivacaine that will provide effective analgesia for 95% of parturients in the first stage of labor. The verbal numeric rating scale (VNRS) is used to rate the pain felt over the first 20 minutes, where 0 is no pain and 10 is the worst pain imaginable. After 20 minutes, if the VNRS was greater than 2, the volume of bupivacaine was considered inadequate and additional medication was given.
The volume of bupivacaine for the first patient was arbitrarily chosen as 8 ml, and the dose for each subsequent patient depends on the outcome of the previous injection. Doses will be increased or decreased in increments of 1 ml. If the previous response was ineffective, the next patient will receive 1 ml more than the last patient. If the response of the previous patient is effective, the Narayana rule, which is used to cluster doses around EV95, will be applied to determine if the dose remains the same or decreases.
50 patients will be included in the study. An estimate of EV95 will be calculated based on a logistic model with non-log-transformed doses, fit using Firth's penalized maximum likelihood approach for small sample bias correction. Confidence intervals will be calculated based on the profile likelihood approach.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450099
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Jose CA Carvalho, MD PhD||Mount Sinai Hospital, New York|