Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Phase 4

Terminated

• Conditions: Labor Pain
• Interventions: Drug: Tetracaine; Drug: Bupivacaine

• Registration Number: NCT01005459
• Lead Sponsor: Wake Forest University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study First Posted: 2009-11-01
• Primary Completion: 2011-12-12
• Study Completion: 2011-12-12
• Status Verified: 2017-06
• Results First Submitted: 2017-06-16
• Results First Submitted QC: 2017-06-16
• Results First Posted: 2017-07-13
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tetracaine 2mg	Tetracaine	-
Bupivacaine 2 mg	Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Spinal Analgesic Duration	1-2 hrs	duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete

Trial Locations

Locations (1)

Forsyth Medical Center- OB Anesthesia dept; 🇺🇸 Winston-Salem, North Carolina, United States