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. 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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for not_applicable pain

Timeline

Completed

Started Oct 2013

Shorter than P25 for not_applicable pain

Geographic Reach

1 country

1 active site

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

Study Start

First participant enrolled

October 1, 2013

Completed

23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 30, 2013

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed

Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

6 months

First QC Date

October 24, 2013

Last Update Submit

June 3, 2014

Conditions

Pain

Keywords

EpiduralLabor AnalgesiaBupivacaineMinimum effective volume

Outcome Measures

Primary Outcomes (1)

VNRS pain score
The efficacy of the loading dose will be defined as a pain score ≤ 1 at 20 minutes following injection of the loading dose.
20 minutes

Secondary Outcomes (3)

Dermatome sensory level
20 min
Motor block
20 min
Hypotension
20 min

Study Arms (14)

bupivacaine-fentanyl 4

ACTIVE COMPARATOR

Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 4mL of 0.125% bupivacaine-fentanyl 5mcg/mL.

Drug: Bupivacaine-fentanyl

bupivacaine-fentanyl 6

ACTIVE COMPARATOR

Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 6mL of 0.125% bupivacaine-fentanyl 5mcg/mL.

Drug: Bupivacaine-fentanyl

bupivacaine-fentanyl 8

ACTIVE COMPARATOR

Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 8mL of 0.125% bupivacaine-fentanyl 5mcg/mL.

Drug: Bupivacaine-fentanyl

bupivacaine-fentanyl 10

ACTIVE COMPARATOR

Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 10mL of 0.125% bupivacaine-fentanyl 5mcg/mL.

Drug: Bupivacaine-fentanyl

bupivacaine-fentanyl 12

ACTIVE COMPARATOR

Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 12mL of 0.125% bupivacaine-fentanyl 5mcg/mL.

Drug: Bupivacaine-fentanyl

bupivacaine-fentanyl 14

ACTIVE COMPARATOR

Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 14mL of 0.125% bupivacaine-fentanyl 5mcg/mL.

Drug: Bupivacaine-fentanyl

bupivacaine-fentanyl 16

ACTIVE COMPARATOR

Test dose: 3mL of 0.125% bupivacaine-fentanyl 5mcg/mL. Loading dose: 16mL of 0.125% bupivacaine-fentanyl 5mcg/mL.

Drug: Bupivacaine-fentanyl