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Continuous Labor Epidural Catheter for Tubal Ligation Study

NCT ID: NCT00898443

Last Updated: 2012-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Tubal Ligation Bilateral Tubal Ligation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Spinal Anesthetic Group

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

Group Type OTHER

Spinal anesthetic

Intervention Type OTHER

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

Epidural Anesthetic Group

This is the experimental group for this study.

Group Type EXPERIMENTAL

Epidural anesthetic

Intervention Type OTHER

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

Interventions

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Epidural anesthetic

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

Intervention Type OTHER

Spinal anesthetic

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Marsha Wakefield, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marsha L. Wakefield, MD

Role: PRINCIPAL_INVESTIGATOR

UAB Department of Anesthesiology

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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F080829007

Identifier Type: -

Identifier Source: org_study_id