Overview

This trial is active, not recruiting.

Condition labor pain
Treatments tetracaine, bupivacaine
Sponsor Wake Forest School of Medicine
Start date August 2009
End date December 2016
Trial size 60 participants
Trial identifier NCT01005459, IRB 9824

Summary

The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
tetracaine
Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
(Active Comparator)
bupivacaine
Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

Primary Outcomes

Measure
Spinal analgesic duration
time frame: 1-2 hrs

Eligibility Criteria

Female participants at least 12 years old.

Inclusion Criteria: - early labor (>=2cm but =<6cm cervical dilation) - at least 12 years of age - have an assigned ASA physical status 1 or 2 - singleton pregnancy Exclusion Criteria: - contraindications to neuraxial anesthesia - with allergies to drugs used in the study - have an assigned ASA status 3 or 4 - advanced labor (> 6cm cervical dilation) - less than 12 years of age - Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.

Additional Information

Official title Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia
Principal investigator Peter H. Pan, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.