Trial Outcomes & Findings for Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE (NCT NCT01005459)

Last Updated: 2017-11-08

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

1-2 hrs

Results posted on

2017-11-08

Participant Flow

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

Participant milestones

Participant milestones
Measure	Tetracaine 2mg Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.	Bupivacaine 2 mg Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Overall Study STARTED	23	23
Overall Study COMPLETED	23	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tetracaine Combined Spinal Epidural (CSE) Versus Bupivacaine CSE

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tetracaine 2mg n=23 Participants Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.	Bupivacaine 2 mg n=23 Participants Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	23 Participants n=4 Participants	46 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized white	18 Participants n=93 Participants	17 Participants n=4 Participants	35 Participants n=27 Participants
Race/Ethnicity, Customized african american	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized hispanic	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized other	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	23 participants n=93 Participants	23 participants n=4 Participants	46 participants n=27 Participants

PRIMARY outcome

Timeframe: 1-2 hrs

Outcome measures

Outcome measures
Measure	Tetracaine 2mg n=23 Participants Tetracaine: Tetracaine 2mg will be combined with Fentanyl 20 mcg and Epinephrine 50 mcg to treat labor pain.	Bupivacaine 2 mg n=23 Participants Bupivacaine: Bupivacaine 2 mg combined with fentanyl 20 mcg and Epinephrine 50 mcg will be used to treat labor pain.
Spinal Analgesic Duration	92.68 minutes Standard Deviation 46.71	89.61 minutes Standard Deviation 27.39

Adverse Events

Tetracaine 2mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine 2 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter H. Pan MD, MSEE

Wake Forest School of Medicine-Anesthesiology

Phone: 336-718-8278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place