Continuous Labor Epidural Catheter for Tubal Ligation Study
This study has been terminated.
Sponsor:
University of Alabama at Birmingham
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
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 May 21, 2013