Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450099
Status:
COMPLETED
Last Update Posted:
2007-12-17
First Post:
2007-03-19
Brief Title:
Minimum Local Anesthetic Volume of Bupivacaine in Labour Epidurals
Sponsor:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Organization:
Samuel Lunenfeld Research Institute Mount Sinai Hospital
Study Overview
Official Title:
Determination of the Minimum Local Anesthetic Volume of 0125 Bupivacaine in Labour Epidurals
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Our hypothesis is that for each concentration of a certain drug there has to be a minimum effective volume that will be associated with the best possible performance of the drug This study is being conducted to find the minimum volume of bupivacaine a local anesthetic that produces successful analgesia in 95 of patients in labor
Detailed Description:
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 0125 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 Firths penalized maximum likelihood approach for small sample bias correction Confidence intervals will be calculated based on the profile likelihood approach
This study is conducted as a prospective randomized up-down sequential allocation trial The aim is to determine the minimum volume of 0125 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 Firths penalized maximum likelihood approach for small sample bias correction Confidence intervals will be calculated based on the profile likelihood approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-0209-E | None | None | None |