NCT01005459

Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Wake Forest University · Academic / Other
• Sex: Female
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Labor Pain

Interventions

Type	Name	Description
DRUG	Tetracaine	Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
DRUG	Bupivacaine	Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-12-12
• Completion: 2011-12-12
• First posted: 2009-11-02
• Last updated: 2017-11-08
• Results posted: 2017-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study