Efficacy of Labor Epidurals for Postpartum Tubal Ligation

Not Applicable

Terminated

• Conditions: Pregnancy
• Interventions: Drug: Normal Saline Infusion; Other: Capped Epidural

• Registration Number: NCT02564016
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2018-06-19
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Results First Posted: 2018-11-14
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal 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
Capped Epidural	Capped Epidural	Group 1 (control) will have the epidural catheter capped and left in place.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Successful Epidural Reactivation	one year	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.

Secondary Outcome Measures

Name	Time	Method
Count of Participants Who Experienced Epidural Reactivation Failure	one year
Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.	one year

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States