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Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Labor Pain

Intervention: Tetracaine (Drug); Bupivacaine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Peter H. Pan, MD, Principal Investigator, Affiliation: WFUHS

Overall contact:
Lynnette Harris, BSN, Phone: 336-718-6049, Email: lcharris@wfubmc.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Spinal analgesic duration

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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.

Locations and Contacts

Lynnette Harris, BSN, Phone: 336-718-6049, Email: lcharris@wfubmc.edu

Forsyth Medical Center-Sara Lee Center for Women's Health - OB Anesthesia dept, Winston-Salem, North Carolina 27103, United States; Recruiting
Lynnette C Harris, BSN, Phone: 336-718-6049, Email: lcharris@wfubmc.edu
John A Thomas, MD, Sub-Investigator
Laura Dean, MD, Sub-Investigator
Daniel Forest, MD, Sub-Investigator
Kenneth Nelson, MD, Sub-Investigator
Robert D'Angelo, MD, Sub-Investigator
Vernon Ross, MD, Sub-Investigator
Ashley Tonidandel, MD, Sub-Investigator
David Hood, MD, Sub-Investigator
Medge Owen, MD, Sub-Investigator
Terrence Bogard, MD, Sub-Investigator
Additional Information

Starting date: August 2009
Last updated: June 4, 2014

Page last updated: August 23, 2015

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