Efficacy of Labor Epidurals for Postpartum Tubal Ligation

Medical University of South Carolina (MUSC)

Status: Terminated

Conditions: Pregnancy

Treatments: Drug: Normal Saline Infusion; Other: Capped Epidural

Study type: Interventional

Funder types: Other

Identifiers

NCT02564016

Pro00033454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Capped Epidural

Active Comparator group

Description:

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

Treatment:

Other: Capped Epidural

Normal Saline Infusion

Experimental group

Description:

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

Treatment:

Drug: Normal Saline Infusion