Continuous Labor Epidural Catheter for Tubal Ligation Study

Tubal Ligation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00898443
• Other study ID #: F080829007
• Status: Terminated
• Phase: N/A
• First received: May 8, 2009
• Last updated: June 26, 2012
• Start date: October 2008
• Est. completion date: August 2010

Study information

• Verified date: June 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bilateral Tubal Ligation
• Tubal Ligation

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation	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	No
Secondary	Impact of Anesthesia Type on OR (Operating Room) Efficiency	The time minutes)from initiation of anesthesia to surgery start.	minutes until surgery start	No