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Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Tracking Information
First Submitted Date  ICMJE October 30, 2009
First Posted Date  ICMJE November 2, 2009
Results First Submitted Date  ICMJE June 16, 2017
Results First Posted Date  ICMJE July 13, 2017
Last Update Posted Date November 8, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date December 12, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 30, 2009)
Spinal Analgesic Duration [ Time Frame: until delivery ]
Change History Complete list of historical versions of study NCT01005459 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE
Official Title  ICMJE Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Labor Pain
Intervention  ICMJE
  • Drug: Tetracaine
    Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
  • Drug: Bupivacaine
    Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Study Arms  ICMJE
  • Active Comparator: tetracaine 2mg
    Intervention: Drug: Tetracaine
  • Active Comparator: Bupivacaine 2 mg
    Intervention: Drug: Bupivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 23, 2017)
46
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2009)
60
Actual Study Completion Date  ICMJE December 12, 2011
Actual Primary Completion Date December 12, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01005459
Other Study ID Numbers  ICMJE IRB 9824
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences ( Wake Forest University )
Study Sponsor  ICMJE Wake Forest University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter H. Pan, MD WFUHS
PRS Account Wake Forest University Health Sciences
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP