Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01005459
First received: October 30, 2009
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Labor Pain
Drug: Tetracaine
Drug: Bupivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Spinal analgesic duration [ Time Frame: 1-2 hrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tetracaine 2mg Drug: Tetracaine
Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
Active Comparator: Bupivacaine 2 mg Drug: Bupivacaine
Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005459

Contacts
Contact: Lynnette Harris, BSN 336-718-6049 lcharris@wfubmc.edu

Locations
United States, North Carolina
Forsyth Medical Center-Sara Lee Center for Women's Health - OB Anesthesia dept Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Lynnette C Harris, BSN    336-718-6049    lcharris@wfubmc.edu   
Sub-Investigator: 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         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Peter H. Pan, MD WFUHS
  More Information

No publications provided

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Professor of Anesthesiology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01005459     History of Changes
Other Study ID Numbers: IRB 9824
Study First Received: October 30, 2009
Last Updated: June 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
labor pain
combined spinal epidural labor analgesia
CSE analgesia
labor analgesia

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bupivacaine
Tetracaine
Epinephrine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on September 16, 2014