Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study | NCT07720908

NCT07720908

Overview

NCT ID: NCT07720908
Lead Sponsor: Ohio State UniversityOTHER
Official Title: Assessing Labor Epidural Catheter Dysfunction for Tubal Ligation in Parturients Using CompuFlo® CathCheck™ System: A Pilot Study
Brief 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.
Conditions: Anesthesia, Epidural
Interventions

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Dec 19, 2024Actual
Primary Completion Date: Oct 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 120Estimated
Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Ling-Qun Hu, MDContact
LingQun.Hu@osumc.edu6142933559

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Masking Description

This is an open-label study. Participants, anesthesia care providers, investigators, and outcome assessors are not masked to the CompuFlo® CathCheck™ System assessment. The device evaluation is performed as part of the study procedures, and the results are recorded prospectively. The primary outcome is based on predefined objective clinical criteria for successful labor epidural catheter reactivation, including sensory block assessment and the need for conversion to another anesthetic technique or additional anesthetic interventions.