Continuous Labor Epidural Catheter for Tubal Ligation Study
- Conditions
- Tubal LigationBilateral Tubal Ligation
- Interventions
- Other: Spinal anestheticOther: Epidural anesthetic
- Registration Number
- NCT00898443
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 18
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spinal Anesthetic Group Spinal anesthetic This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study. Epidural Anesthetic Group Epidural anesthetic This is the experimental group for this study.
- Primary Outcome Measures
Name Time Method Success Rate of Reactivation of Existing Continuous Labor Epidural Catheter for Postpartum Tubal Ligation 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
Name Time Method Impact of Anesthesia Type on OR (Operating Room) Efficiency minutes until surgery start The time minutes)from initiation of anesthesia to surgery start.
Trial Locations
- Locations (1)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States