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Continuous Labor Epidural Catheter for Tubal Ligation Study

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ClinicalTrials.gov Identifier: NCT00898443
Recruitment Status : Terminated
First Posted : May 12, 2009
Results First Posted : August 7, 2012
Last Update Posted : August 7, 2012
Sponsor:
Information provided by (Responsible Party):
Marsha Wakefield, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Tubal Ligation Bilateral Tubal Ligation Other: Epidural anesthetic Other: Spinal anesthetic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Success Rate, Efficiency, and Predictors of Reactivation of a Continuous Labor Epidural Catheter for Postpartum Tubal Ligation
Study Start Date : October 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.)


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898443


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Marsha L. Wakefield, MD UAB Department of Anesthesiology
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Responsible Party: Marsha Wakefield, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00898443    
Other Study ID Numbers: F080829007
First Posted: May 12, 2009    Key Record Dates
Results First Posted: August 7, 2012
Last Update Posted: August 7, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs