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Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Primary Purpose

Labor Pain

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tetracaine
Bupivacaine
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor pain, combined spinal epidural labor analgesia, CSE analgesia, labor analgesia

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Forsyth Medical Center- OB Anesthesia dept

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

tetracaine 2mg

Bupivacaine 2 mg

Arm Description

Outcomes

Primary Outcome Measures

Spinal Analgesic Duration
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

Secondary Outcome Measures

Full Information

First Posted
October 30, 2009
Last Updated
November 6, 2017
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT01005459
Brief Title
Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
Official Title
Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
feasibility /drug availability issues - No study drug sources available
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 12, 2011 (Actual)
Study Completion Date
December 12, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
labor pain, combined spinal epidural labor analgesia, CSE analgesia, labor analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tetracaine 2mg
Arm Type
Active Comparator
Arm Title
Bupivacaine 2 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tetracaine
Intervention Description
Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Primary Outcome Measure Information:
Title
Spinal Analgesic Duration
Description
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
Time Frame
1-2 hrs

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter H. Pan, MD
Organizational Affiliation
WFUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forsyth Medical Center- OB Anesthesia dept
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States

12. IPD Sharing Statement

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Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

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