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
  Purpose

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.


Condition Intervention
Tubal Ligation
Bilateral Tubal Ligation
Other: Epidural anesthetic
Other: Spinal anesthetic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Success Rate, Efficiency, and Predictors of Reactivation of a Continuous Labor Epidural Catheter for Postpartum Tubal Ligation

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.)


Secondary Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: October 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898443

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Marsha L. Wakefield, MD UAB Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Marsha Wakefield, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00898443     History of Changes
Other Study ID Numbers: F080829007
Study First Received: May 8, 2009
Results First Received: April 19, 2012
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014