Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01005459
• Other study ID #: IRB 9824
• Status: Terminated
• Phase: Phase 4
• First received: October 30, 2009
• Last updated: November 6, 2017
• Start date: August 2009
• Est. completion date: December 12, 2011

Study information

• Verified date: June 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: December 12, 2011
• Est. primary completion date: December 12, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Tetracaine
Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
• Bupivacaine
Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

Locations

Country	Name	City	State
United States	Forsyth Medical Center- OB Anesthesia dept	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal Analgesic Duration	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	1-2 hrs