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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
120
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.
The Ohio State University
Columbus, Ohio, United States
RECRUITINGRate of Successful Labor Epidural Catheter Reactivation
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).
Time frame: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)
Sensitivity of the CompuFlo® CathCheck™ System
The sensitivity percentage of the CompuFlo® CathCheck™ System for correctly identifying functional labor epidural catheters that successfully provide anesthesia for postpartum tubal ligation.
Time frame: Pre-procedural (prior to epidural reactivation)
Specificity of the CompuFlo® CathCheck™ System
The specificity percentage of the CompuFlo® CathCheck™ System for correctly identifying non-functional labor epidural catheters.
Time frame: Pre-procedural (prior to epidural reactivation)
Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System
The AUC value of the CompuFlo® CathCheck™ System to evaluate its overall diagnostic performance in discriminating between functional and non-functional labor epidural catheters.
Time frame: Pre-procedural (prior to epidural reactivation)
Number of Dermatomal Sensory Block Levels After Epidural Test Dose
The number of dermatomal levels demonstrating loss of cold sensation following a standard epidural local anesthetic test dose.
Time frame: Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)
Duration of Labor Epidural Catheter Unused Time
The total duration of time (measured in hours) between the completion of labor analgesia and the attempted epidural reactivation for the tubal ligation.
Time frame: Periprocedural (from delivery until epidural reactivation)
Frequency of Labor Epidural Top-Up Doses
The total number of supplemental epidural local anesthetic bolus doses administered during labor prior to delivery.
Time frame: Intrapartum (from labor epidural placement until delivery)
Postoperative Pain Intensity via Numeric Rating Scale (NRS-11)
Pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Time frame: Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)
Patient Satisfaction Score With Labor Analgesia
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").
Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
Patient Satisfaction Score With Tubal Ligation Anesthesia
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").
Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
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