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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 )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Labor Pain
Interventions Drug: Tetracaine
Drug: Bupivacaine
Enrollment 46
Recruitment Details Participants were approached after admission to the labor and delivery unit of our hospital about participation in this study
Pre-assignment Details  
Arm/Group Title Tetracaine 2mg Bupivacaine 2 mg
Hide Arm/Group Description Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain. Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Period Title: Overall Study
Started 23 23
Completed 23 23
Not Completed 0 0
Arm/Group Title Tetracaine 2mg Bupivacaine 2 mg Total
Hide Arm/Group Description Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain. Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain. Total of all reporting groups
Overall Number of Baseline Participants 23 23 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
23
 100.0%
23
 100.0%
46
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
Female
23
 100.0%
23
 100.0%
46
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 23 participants 46 participants
white
18
  78.3%
17
  73.9%
35
  76.1%
african american
5
  21.7%
2
   8.7%
7
  15.2%
hispanic
0
   0.0%
3
  13.0%
3
   6.5%
other
0
   0.0%
1
   4.3%
1
   2.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 23 participants 46 participants
23 23 46
1.Primary Outcome
Title Spinal Analgesic Duration
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tetracaine 2mg Bupivacaine 2 mg
Hide Arm/Group Description:
Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.
Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Overall Number of Participants Analyzed 23 23
Mean (Standard Deviation)
Unit of Measure: minutes
92.68  (46.71) 89.61  (27.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tetracaine 2mg
Comments [Not Specified]
Type of Statistical Test Other
Comments unpaired t-test
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method unpaired t-test compared between groups
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Bupivacaine 2 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments unpaired t-test compared between groups
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method unpaired t-test compared between groups
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tetracaine 2mg Bupivacaine 2 mg
Hide Arm/Group Description Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain. Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
All-Cause Mortality
Tetracaine 2mg Bupivacaine 2 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tetracaine 2mg Bupivacaine 2 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tetracaine 2mg Bupivacaine 2 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter H. Pan MD, MSEE
Organization: Wake Forest School of Medicine-Anesthesiology
Phone: 336-718-8278
EMail: ppan@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( 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