Clinical trial NCT02564016: Efficacy of Labor Epidurals for Postpartum Tubal Ligation
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Epidural Reactivation
timeFrame: one year
Secondary outcomes:
measure: Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.
timeFrame: one year
measure: Count of Participants Who Experienced Epidural Reactivation Failure
timeFrame: one year
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Laura Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References: