Continuous Labor Epidural Catheter for Tubal Ligation Study

NCT00898443 | Terminated Results DMC

• 1 other identifier: F080829007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Tubal Ligation; Bilateral Tubal Ligation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Impact of Anesthesia Type on OR (Operating Room) Efficiency

  minutes until surgery start

Study Arms (2)

Spinal Anesthetic Group

OTHER

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

Other: Spinal anesthetic

Epidural Anesthetic Group

EXPERIMENTAL

This is the experimental group for this study.

Other: Epidural anesthetic

Interventions

Epidural anesthetic OTHER

Use of the existing continuous labor epidural for surgical anesthetic for postpartum tubal ligation

Epidural Anesthetic Group

Spinal anesthetic OTHER

This group was assigned to receive spinal anesthetic for postpartum tubal ligation.

Spinal Anesthetic Group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Interventions

Anesthesia, Spinal

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Marsha Wakefield, M.D.
• Organization: UAB

mwakefield@uab.edu

205-934-4696

Study Officials

• Marsha L. Wakefield, MD

  UAB Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Study Start: October 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 7, 2012
• Results First Posted: August 7, 2012

Record last verified: 2012-06

Locations

US (1)