Continuous Labor Epidural Catheter for Tubal Ligation Study

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Marsha Wakefield, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT00898443

First received: May 8, 2009

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 8, 2009

Last Updated Date

June 26, 2012

Start Date ^ICMJE

October 2008

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation [ Time Frame: at the time of surgery ] [ Designated as safety issue: No ]

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.)

Original Primary Outcome Measures ^ICMJE

Success rate of reactivation of existing continuous labor epidural catheter for postpartum tubal ligation [ Time Frame: at the time of surgery ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00898443 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Impact of Anesthesia Type on OR (Operating Room) Efficiency [ Time Frame: minutes until surgery start ] [ Designated as safety issue: No ]

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Continuous Labor Epidural Catheter for Tubal Ligation Study

Official Title ^ICMJE

Success Rate, Efficiency, and Predictors of Reactivation of a Continuous Labor Epidural Catheter for Postpartum Tubal Ligation

Brief Summary

This study is to study the success rate of using the epidural catheter that was placed during the labor for the surgical anesthesia to perform a postpartum tubal ligation.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Tubal Ligation
Bilateral Tubal Ligation

Intervention ^ICMJE

Other: Epidural anesthetic
Use of the existing continuous labor epidural for surgical anesthetic for postpartum tubal ligation
Other: Spinal anesthetic
This group was assigned to receive spinal anesthetic for postpartum tubal ligation.

Study Arm (s)

Spinal Anesthetic Group
This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.

Intervention: Other: Spinal anesthetic
Experimental: Epidural Anesthetic Group
This is the experimental group for this study.

Intervention: Other: Epidural anesthetic

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

Enrollment ^ICMJE

Completion Date

August 2010

Primary Completion Date

August 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

American Society of Anesthesiologists (ASA) 1-3 postpartum women desiring Postpartum Bilateral Tubal Ligation (PPBTL) for infertility
Functional epidural catheter placed for labor and delivery analgesia
The epidural is still taped within 1cm of the original depth when it was functional for labor analgesia
1-45 years of age

Exclusion Criteria:

ASA 4 status
History of dural puncture ("wet tap") during initial epidural catheter insertion
History of marginal or inadequate epidural analgesia for labor
Cesarean section for delivery
Examination demonstrates that the indwelling catheter has migrated more than 1 cm from the original depth when secured
The end of indwelling epidural catheter appears to have not been capped appropriately or the cap was not maintained intact
Prolonged sensory or motor block, bladder or anal sphincter dysfunction, nerve damage, inability to ambulate, post-dural puncture headache (PDHD), or seizures, during or after delivery and following cessation of the epidural catheter dosing
Pseudocholinesterase deficiency
Allergy to Nesacaine® (chloroprocaine) or lidocaine
General anesthesia provided for delivery
History of substance abuse disorder
History of major psychiatric disorder
Non-English reading/speaking participants

Gender

Female

Ages

19 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00898443

Other Study ID Numbers ^ICMJE

F080829007

Has Data Monitoring Committee

Yes

Responsible Party

Marsha Wakefield, MD, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Marsha L. Wakefield, MD

UAB Department of Anesthesiology

Information Provided By

University of Alabama at Birmingham

Verification Date

June 2012

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

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