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NCT Number: NCT07720908

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CompuFlo® CathCheck™ System Assessment

Device

Evaluation of labor epidural catheter functionality using the CompuFlo® CathCheck™ System following standard epidural test-dose administration and prior to epidural reactivation for postpartum tubal ligation.

Primary outcomes

  1. Rate of Successful Labor Epidural Catheter Reactivation

    Time frame: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)

    The percentage of participants with successful use of the existing labor epidural catheter for postpartum tubal ligation without evidence of catheter failure or the need for alternative anesthesia techniques (e.g., conversion to general anesthesia or spinal anesthesia).

Secondary outcomes

  1. Sensitivity of the CompuFlo® CathCheck™ System

    Time frame: Pre-procedural (prior to epidural reactivation)

    The sensitivity percentage of the CompuFlo® CathCheck™ System for correctly identifying functional labor epidural catheters that successfully provide anesthesia for postpartum tubal ligation.

  2. Specificity of the CompuFlo® CathCheck™ System

    Time frame: Pre-procedural (prior to epidural reactivation)

    The specificity percentage of the CompuFlo® CathCheck™ System for correctly identifying non-functional labor epidural catheters.

  3. Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System

    Time frame: Pre-procedural (prior to epidural reactivation)

    The AUC value of the CompuFlo® CathCheck™ System to evaluate its overall diagnostic performance in discriminating between functional and non-functional labor epidural catheters.

  4. Number of Dermatomal Sensory Block Levels After Epidural Test Dose

    Time frame: Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)

    The number of dermatomal levels demonstrating loss of cold sensation following a standard epidural local anesthetic test dose.

  5. Duration of Labor Epidural Catheter Unused Time

    Time frame: Periprocedural (from delivery until epidural reactivation)

    The total duration of time (measured in hours) between the completion of labor analgesia and the attempted epidural reactivation for the tubal ligation.

  6. Frequency of Labor Epidural Top-Up Doses

    Time frame: Intrapartum (from labor epidural placement until delivery)

    The total number of supplemental epidural local anesthetic bolus doses administered during labor prior to delivery.

  7. Postoperative Pain Intensity via Numeric Rating Scale (NRS-11)

    Time frame: Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)

    Pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), where 0 represents "no pain" and 10 represents "the worst pain imaginable."

  8. Patient Satisfaction Score With Labor Analgesia

    Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])

    Patient-reported satisfaction with labor epidural analgesia, assessed using a standard Likert scale (e.g., 1-5 scale, where 1 is "highly dissatisfied" and 5 is "highly satisfied").

  9. Patient Satisfaction Score With Tubal Ligation Anesthesia

    Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])

    Patient-reported satisfaction with anesthetic management during the postpartum tubal ligation procedure, assessed using a standard Likert scale (e.g., 1-5 scale, where 1 is "highly dissatisfied" and 5 is "highly satisfied").

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Uribe Vega

CONTACT

[email protected]

6142933559

Ling-Qun Hu, MD

CONTACT

[email protected]

6142933559

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Assessing Labor Epidural Catheter Dysfunction for Tubal Ligation in Parturients Using CompuFlo® CathCheck™ System: A Pilot Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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