Efficacy of Labor Epidurals for Postpartum Tubal Ligation

Study Overview
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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.

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.

Official Title
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Efficacy of Labor Epidurals for Postpartum Tubal Ligation: Effect of Postpartum Epidural Saline Infusion on the Reactivation of Labor Epidurals for Postpartum Tubal Ligation Following Vaginal Delivery

Conditions
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Pregnancy

Intervention / Treatment
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* Drug: Normal Saline Infusion
* Other: Capped Epidural


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capped Epidural<br>Group 1 (control) will have the epidural catheter capped and left in place. | Other: Capped Epidural<br>* epidural will be capped with no saline infusion.<br>|
| Experimental: Normal Saline Infusion<br>Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour | Drug: Normal Saline Infusion<br>* Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour<br>* Other names: 0.9% Sodium Chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Epidural Reactivation | 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery. |  | one year | 
| Count of Participants Who Experienced Epidural Reactivation Failure |  | one year |