Anesthesia, Epidural
Conditions
Keywords
Labor epidural catheter, Epidural catheter dysfunction, CompuFlo CathCheck System, Tubal ligation in parturients
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.
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.
Interventions
DEVICECompuFlo® CathCheck™ System Assessment
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.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Intervention model description
All enrolled participants will undergo the same study procedures. Following vaginal delivery and prior to postpartum tubal ligation, participants with an indwelling labor epidural catheter will receive the standard clinical epidural test dose and assessment, followed by evaluation with the CompuFlo® CathCheck™ System to detect epidural pulsatile waveform pressure. The diagnostic performance of the CompuFlo® system will be compared with the clinical reference standard for successful epidural catheter reactivation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Successful Labor Epidural Catheter Reactivation | 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the CompuFlo® CathCheck™ System | 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. |
| Specificity of the CompuFlo® CathCheck™ System | Pre-procedural (prior to epidural reactivation) | The specificity percentage of the CompuFlo® CathCheck™ System for correctly identifying non-functional labor epidural catheters. |
| Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System | 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. |
| Number of Dermatomal Sensory Block Levels After Epidural Test Dose | 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. |
| Duration of Labor Epidural Catheter Unused Time | 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. |
| Frequency of Labor Epidural Top-Up Doses | Intrapartum (from labor epidural placement until delivery) | The total number of supplemental epidural local anesthetic bolus doses administered during labor prior to delivery. |
| Postoperative Pain Intensity via Numeric Rating Scale (NRS-11) | 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." |
| Patient Satisfaction Score With Labor Analgesia | 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"). |
| Patient Satisfaction Score With Tubal Ligation Anesthesia | 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"). |
Countries
United States
Contacts
CONTACTLing-Qun Hu, MD
CONTACTAlberto Uribe Vega
Outcome results
None listed