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
|