Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

• Sponsor: Wake Forest University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01005459
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Duration (Months): 28.4
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Tetracaine; Drug: Bupivacaine	Phase 4

Study Design

• Study Type: Interventional
• 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: Aug 1, 2009
• Actual Primary Completion Date: Dec 12, 2011
• Actual Study Completion Date: Dec 12, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Spinal Analgesic Duration [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wake Forest University
• ClinicalTrials.gov Identifier: NCT01005459
• Other Study ID Numbers: IRB 9824
• First Posted: Nov 1, 2009
• Last Update Posted: Nov 8, 2017
• Last Verified: Jun 1, 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: labor pain; combined spinal epidural labor analgesia; CSE analgesia; labor analgesia
• Additional relevant MeSH terms: Labor Pain; Bupivacaine; Tetracaine

Study Results

Participant Flow

Recruitment Details	Participants were approached after admission to the labor and delivery unit of our hospital about participation in this study

Arm/Group Title	Tetracaine 2mg	Bupivacaine 2 mg
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

Baseline Characteristics

Arm/Group Title	Tetracaine 2mg	Bupivacaine 2 mg	Total
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 Participants	23	23	46
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	23 100%	23 100%	46 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	23 100%	23 100%	46 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of 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%	3 13%	3 6.5%
other	0 0%	1 4.3%	1 2.2%
Region of Enrollment (participants) [Number]
United States	23 100%	23 100%	46 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tetracaine 2mg	Bupivacaine 2 mg
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.
Measure Participants	23	23
Mean (Standard Deviation) [minutes]	92.68 (46.71)	89.61 (27.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tetracaine 2mg
	Comments
	Type of Statistical Test	Other
	Comments	unpaired t-test
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	unpaired t-test compared between groups
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine 2 mg
	Comments
	Type of Statistical Test	Other
	Comments	unpaired t-test compared between groups
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	unpaired t-test compared between groups
	Comments

Adverse Events

Arm/Group Title	Tetracaine 2mg		Bupivacaine 2 mg
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Tetracaine 2mg		Bupivacaine 2 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Tetracaine 2mg		Bupivacaine 2 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.