Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

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. Identifier: NCT01005459
Recruitment Status : Terminated (feasibility /drug availability issues - No study drug sources available)
First Posted : November 2, 2009
Results First Posted : July 13, 2017
Last Update Posted : November 8, 2017
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Brief 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.

Condition or disease Intervention/treatment Phase
Labor Pain Drug: Tetracaine Drug: Bupivacaine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Study Start Date : August 2009
Primary Completion Date : December 12, 2011
Study Completion Date : December 12, 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01005459

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

Responsible Party: Wake Forest University Identifier: NCT01005459     History of Changes
Other Study ID Numbers: IRB 9824
First Posted: November 2, 2009    Key Record Dates
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
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Epinephryl borate
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
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