Efficacy of Labor Epidurals for Postpartum Tubal Ligation

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02564016
• Other study ID #: Pro00033454
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: October 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Other:
• Capped Epidural
epidural will be capped with no saline infusion.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Count of Participants Whose BMI Affected the Reactivation Rate of Labor Epidurals for Postpartum Tubal Ligation Surgery Following Vaginal Delivery.		one year
Secondary	Count of Participants Who Experienced Epidural Reactivation Failure		one year