Trial Outcomes & Findings for Continuous Labor Epidural Catheter for Tubal Ligation Study (NCT NCT00898443)

Results Overview

Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

at the time of surgery

Results posted on

2012-08-07

Participant Flow

Women in labor, admitted to UAB Labor \& Delivery, who requested postpartum tubal ligation after delivery.

Participant milestones

Participant milestones
Measure	Spinal Anesthetic Group This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.	Epidural Anesthetic Group This is the experimental group for this study.
Overall Study STARTED	10	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Spinal Anesthetic Group This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.	Epidural Anesthetic Group This is the experimental group for this study.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Continuous Labor Epidural Catheter for Tubal Ligation Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spinal Anesthetic Group n=9 Participants This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.	Epidural Anesthetic Group n=8 Participants This is the experimental group for this study.	Total n=17 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	9 Participants n=93 Participants	8 Participants n=4 Participants	17 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	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	9 participants n=93 Participants	8 participants n=4 Participants	17 participants n=27 Participants

PRIMARY outcome

Timeframe: at the time of surgery

Population: Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.

Rate of reactivation of the epidural catheter for postpartum tubal ligation in the group that was randomized to the epidural anesthetic group. (Need for additional supplemental analgesics and sedatives or the need to convert to general anesthesia.)

Outcome measures

Outcome measures
Measure	Spinal Anesthetic Group n=9 Participants This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.	Epidural Anesthetic Group n=8 Participants This is the experimental group for this study.
Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation	0 participants 0	7 participants 0

SECONDARY outcome

Timeframe: minutes until surgery start

Population: Only the patients who were recruited, randomized and had all their data completed at the time of their procedure were included in the analysis. Insufficient numbers were recruited to complete the study as designed.

The time minutes)from initiation of anesthesia to surgery start.

Outcome measures

Outcome measures
Measure	Spinal Anesthetic Group n=9 Participants This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.	Epidural Anesthetic Group n=8 Participants This is the experimental group for this study.
Impact of Anesthesia Type on OR (Operating Room) Efficiency	14 minutes Interval 8.0 to 22.0	29 minutes Interval 19.0 to 37.0

Adverse Events

Spinal Anesthetic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural Anesthetic Group

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

Marsha Wakefield, M.D.

UAB

Phone: 205-934-4696

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place