Efficacy of Labor Epidurals for Postpartum Tubal Ligation

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

Brief Summary

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The goal of this study is to evaluate the effect of continuous postpartum epidural saline infusion on the reactivation of labor epidurals for postpartum tubal ligation surgery following vaginal delivery.

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Detailed Description

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The aim of this research is to determine the effect of postpartum epidural saline infusion on the reactivation of labor epidural catheters which are used as the anesthetic technique for PPTL following vaginal delivery. It is proposed that continuous epidural saline infusion will decrease the incidence of catheter obstruction by preventing clot, fibrosis, or tissue plugging and therefore improve reactivation rates. To our knowledge, this is a novel method for attempting to improve epidural reactivation rate and if successful, it would challenge the current practice of only capping epidurals following delivery and later attempting reactivation prior to PPTL. This may, possibly, become a new technique used to improve the rate of epidural reactivation for PPTL.

If study results show improved labor epidural reactivation rates, benefits would include decreased patient morbidity and greater patient comfort and satisfaction by avoiding the risks of additional neuraxial procedures as well as general anesthesia. These risks include difficult or failed intubation, aspiration, hypotension, headache, postoperative nausea and vomiting, and sore throat. Improving epidural reactivation rate could also result in greater OR efficiency and decreased costs for the patient and hospital.

The investigators also hope to elucidate factors associated with catheter migration or dislodgement and subsequent failure of epidural reactivation. Additionally, we hope to determine what effect obesity and length of time prior epidural reactivation have on epidural reactivation rates.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Capped Epidural

Group 1 (control) will have the epidural catheter capped and left in place.

Group Type ACTIVE_COMPARATOR

Capped Epidural

Intervention Type OTHER

epidural will be capped with no saline infusion.

Normal Saline Infusion

Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour

Group Type EXPERIMENTAL

Normal Saline Infusion

Intervention Type DRUG

Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour

Interventions

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Normal Saline Infusion

Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour

Intervention Type DRUG

Capped Epidural

epidural will be capped with no saline infusion.

Intervention Type OTHER

Other Intervention Names

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0.9% Sodium Chloride

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* 18 to 45 years of age
* Admitted to MUSC in labor or for induction of labor resulting in a vaginal delivery epidural analgesia
* Postpartum tubal ligation following delivery
* American Society of Anesthesiologists (ASA) Physical Class 1, 2, and 3

Exclusion Criteria

* Critically Ill Patients (patients admitted to the ICU)
* Cognitively Impaired Persons (patients with a diagnosis of cognitive deficit)
* Cesarean delivery
* Punctured dura
* Patients enrolled in other epidural research studies

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes