Continuous Labor Epidural Catheter for Tubal Ligation Study

June 26, 2012 updated by: Marsha Wakefield, MD, University of Alabama at Birmingham

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Spinal Anesthetic Group
This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
Other: Spinal anesthetic
This group was assigned to receive spinal anesthetic for postpartum tubal ligation.
EXPERIMENTAL: Epidural Anesthetic Group
This is the experimental group for this study.
Other: Epidural anesthetic
Use of the existing continuous labor epidural for surgical anesthetic for postpartum tubal ligation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
Time Frame: at the time of surgery
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.)
at the time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Anesthesia Type on OR (Operating Room) Efficiency
Time Frame: minutes until surgery start
The time minutes)from initiation of anesthesia to surgery start.
minutes until surgery start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Marsha L. Wakefield, MD, UAB Department of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

May 8, 2009

First Submitted That Met QC Criteria

May 8, 2009

First Posted (ESTIMATE)

May 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 7, 2012

Last Update Submitted That Met QC Criteria

June 26, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F080829007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tubal Ligation

Clinical Trials on Spinal anesthetic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe