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Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

This study has been terminated.
(feasibility /drug availability issues - No study drug sources available)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005459
First Posted: November 2, 2009
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  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 Phase
Labor Pain Drug: Tetracaine Drug: Bupivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Spinal Analgesic Duration [ Time Frame: 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


Enrollment: 46
Study Start Date: August 2009
Study Completion Date: December 12, 2011
Primary Completion Date: December 12, 2011 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005459


Locations
United States, North Carolina
Forsyth Medical Center- OB Anesthesia dept
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Peter H. Pan, MD WFUHS
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01005459     History of Changes
Other Study ID Numbers: IRB 9824
First Submitted: October 30, 2009
First Posted: November 2, 2009
Results First Submitted: June 16, 2017
Results First Posted: July 13, 2017
Last Update Posted: November 8, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
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
Fentanyl
Epinephrine
Racepinephrine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents