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NCT07720908NARecruiting

Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study

Ohio State University

Start Date

12/19/2024

Completion Date

12/31/2028

Summary

This pilot study evaluates the use of the CompuFlo® CathCheck™ System to assess labor epidural catheter function before reactivation for postpartum tubal ligation. The study aims to determine whether this technology can accurately identify functional versus dysfunctional epidural catheters compared with standard clinical assessment methods. Improving catheter assessment may reduce failed epidural reactivation, the need for additional anesthesia techniques, and improve patient safety.

Detailed Description

Postpartum tubal ligation is a common surgical procedure performed after delivery, and labor epidural catheters are frequently used for anesthesia during this procedure. However, reactivation of labor epidural catheters after vaginal delivery can fail, requiring conversion to spinal or general anesthesia. Reported failure rates are significant, and factors such as prolonged time since delivery, prior need for additional epidural medication during labor, and poor analgesic satisfaction may increase the risk of failure. Currently, there is no standardized method to confirm the continued function and location of an epidural catheter after childbirth and before reactivation for postpartum procedures. Standard clinical practice typically relies on catheter aspiration, epidural test dosing, and assessment of sensory blockade, but these methods may not reliably identify catheter dysfunction or migration. This prospective pilot cohort study will evaluate the use of the CompuFlo® CathCheck™ System as an additional objective tool for assessing labor epidural catheter function before postpartum tubal ligation. The system uses computerized pressure measurements and pulsatile waveform detection to evaluate epidural catheter placement and patency. Study assessments will be compared with standard clinical evaluation methods to determine the ability of the device to identify functional versus dysfunctional epidural catheters. The primary objective of this study is to assess the diagnostic accuracy of the CompuFlo® CathCheck™ System, including its sensitivity and specificity, in predicting successful epidural catheter reactivation. This study aims to determine whether incorporating objective pressure and waveform measurements can improve identification of catheter dysfunction, reduce failed epidural reactivation, minimize the need for additional anesthesia procedures, and enhance patient safety during postpartum tubal ligation.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria * Age ≥ 18 years * Postpartum women electing to undergo tubal ligation with an indwelling labor epidural catheter * Ability to provide informed consent in English * Vaginal delivery Exclusion Criteria * Parturients not receiving labor epidural analgesia or receiving an alternative anesthetic technique during labor and delivery * Epidural catheter located \>2 cm from the documented insertion depth at initial placement * Planned elective cesarean delivery * Chronic pain conditions (e.g., chronic low back pain, sickle cell disease) * Chronic opioid use disorder * Chronic gabapentin use * Uncontrolled mood disorders that, in the investigator's judgment, may interfere with study participation or interpretation of study outcomes * Prisoners or incarcerated individuals

Interventions

DEVICE

CompuFlo® CathCheck™ System Assessment

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Conditions

Anesthesia, Epidural

Locations

The Ohio State University

Columbus, Ohio 43210

United States