CompuFlo CathCheck for Epidurals

Overseen By Kristine Kancans

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Disqualifiers: Non-English speakers, Pregnant, Bupivacaine allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the CompuFlo CathCheck treatment?

The research on computer-integrated patient-controlled epidural analgesia (CIPCEA) shows that systems which automatically adjust drug delivery based on individual needs can effectively manage pain during labor, suggesting that similar technology in the CompuFlo CathCheck treatment may also be effective in providing personalized pain relief. ^{1 2 3 4 5}

Is the CompuFlo CathCheck system safe for use in humans?

The CompuFlo system has been used in several studies to help identify the epidural space, showing promising results in reducing complications like postdural puncture headache. However, there have been instances of false negatives, suggesting that while it may improve safety, it should be used by experienced practitioners. ^{6 7 8 9 10}

How does the CompuFlo CathCheck treatment differ from other treatments for epidurals?

The CompuFlo CathCheck treatment is unique because it uses a computerized system to provide real-time pressure feedback, helping to accurately identify the epidural space, which can reduce complications and improve the success rate compared to the traditional, more subjective methods. ^{6 7 8 9 10}

Research Team

Aaron Berg

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for adults aged 18-99 who are having an epidural placed for surgery. It's not suitable for those outside this age range or not undergoing the procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo procedures to determine epidural catheter location using Compuflo CathCheck and epidurogram

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

Treatment Details

Interventions

• CompuFlo CathCheck

Trial Overview The study tests if the CompuFlo CathCheck system can accurately locate epidural catheters, comparing it to the gold standard, which is an epidurogram. The results from both methods will be compared to see if they agree.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

CompuFlo CathCheck is already approved in United States for the following indications:

Approved in United States as CompuFlo CathCheck System for:

• Verification of epidural needle placement in the lumbar or thoracic epidural space
• Confirmation of epidural catheter location

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

In a study of 280 nulliparous women using a computer-integrated patient-controlled epidural analgesia (CIPCEA) system, the incidence of breakthrough pain during labor was found to be 9.6%.

Key factors associated with breakthrough pain included dysfunctional labor, higher maternal body mass index, and a low successful-to-total-bolus-demand ratio, which also correlated with decreased maternal satisfaction and increased local anesthetic consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of breakthrough pain in parturients using computer-integrated patient-controlled epidural analgesia. Sng, BL., Zhang, Q., Leong, WL., et al.[2022]

The Go Medical epidural infuser provided effective pain control for 20 patients after elective Caesarean sections, allowing them to manage their own pain relief and maintain good mobility.

Patients reported high satisfaction with the device, and all indicated they would use it again, highlighting its safety and efficacy in a postnatal ward setting despite occasional equipment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable, disposable device for patient-controlled epidural analgesia following Caesarean section: evaluation by patients and nurses. Banks, S., Pavy, T.[2019]

Epidural analgesia (EA) techniques, including continuous and patient-controlled methods, provide modest pain relief at rest compared to intravenous patient-controlled analgesia (IVPCA) after intra-abdominal surgery, with a mean pain reduction of 5.7 points within the first 6 hours and 9.0 points from 7 to 24 hours, based on a review of 32 studies involving 1716 participants.

While EA may offer some benefits in pain management, it is associated with a higher risk of complications such as failure of the analgesic technique, hypotension requiring intervention, and pruritus, indicating that the choice of analgesia should consider both efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults. Salicath, JH., Yeoh, EC., Bennett, MH.[2021]

In a study of 76 parturients, the computer-integrated patient-controlled epidural analgesia (CIPCEA) system showed similar local anesthetic consumption between two groups: one with no initial basal infusion and another with a moderate basal infusion of 5 ml/H, suggesting that the initial infusion may not be necessary.

Both groups experienced comparable levels of breakthrough pain, delivery modes, and patient satisfaction, indicating that CIPCEA can effectively manage pain during labor without significantly impacting fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. Sng, BL., Woo, D., Leong, WL., et al.[2020]

Epidural administration of meperidine through a patient-controlled analgesia (PCA) system provided effective postoperative pain relief for patients undergoing high abdominal surgery, with no significant side effects reported.

Patients using epidural meperidine required less additional analgesia compared to those receiving subcutaneous meperidine, indicating higher satisfaction and better pain management with the epidural method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous epidural perfusion with meperidine on demand for the treatment of postoperative pain]. Balust, J., Boada, J., Taurà, P., et al.[2013]

In a study involving 52 expert anesthesiologists, the CompuFlo® epidural system significantly reduced the needle extension length to just 0.68 mm compared to 3.90 mm with the traditional loss of resistance technique, indicating a more precise identification of the epidural space.

The use of CompuFlo® resulted in less variability in needle placement, making it a more predictable and effective tool for anesthesiologists during epidural procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Needle Extension through the Ligamentum Flavum Using the Standard versus the CompuFlo®-Assisted Loss of Resistance to Saline Technique: A Simulation Study. Capogna, E., Coccoluto, A., Velardo, M.[2022]

The CompuFlo® device was validated as an effective tool for identifying the epidural space during labor epidural analgesia, showing a strong correlation between the pressure readings and the anesthesiologist's sensations (Rho = 0.79).

In cases where trainees faced difficulties with epidural placement, the use of CompuFlo® led to successful epidural analgesia on the first attempt, indicating its potential as a reliable rescue tool in challenging situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental validation of the CompuFlo® epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. Capogna, G., Camorcia, M., Coccoluto, A., et al.[2022]

The CompuFlo® epidural instrument demonstrated a high sensitivity (0.83) and specificity in distinguishing true loss of resistance from false loss of resistance during epidural procedures, based on a study involving 120 healthy women.

Using CompuFlo® can significantly improve the accuracy of epidural space identification, potentially reducing the number of failed attempts and the risk of complications like accidental dural puncture, especially in challenging cases or for less experienced practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiating False Loss of Resistance from True Loss of Resistance While Performing the Epidural Block with the CompuFlo® Epidural Instrument. Vaira, P., Camorcia, M., Palladino, T., et al.[2022]

In a series of 24 epidural procedures using the CompuFlo® technology, the epidural space was successfully identified in 23 cases, demonstrating its high efficacy in clinical practice.

The CompuFlo® device provides objective feedback through pressure curves and acoustic signals, which may help reduce complications associated with traditional techniques, such as postdural puncture headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Identification of the epidural space using pressure waveform analysis (CompuFlo® technology): a case series]. Helf, A., Schlesinger, T., Roewer, N., et al.[2021]

The Compuflo® computerized injection pump can assist in lumbar epidural infiltration by providing real-time pressure monitoring, potentially improving the accuracy of needle placement in chronic pain management.

However, in a study of 60 procedures, there was a 10% false negative rate where the device failed to indicate proper epidural space entry, suggesting that while it can be helpful, it should only be used by experienced practitioners until further investigations clarify its reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure monitoring devices may undetect epidural space: a report on the use of Compuflo® system for epidural injection. Carassiti, M., Pascarella, G., Strumia, A., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of breakthrough pain in parturients using computer-integrated patient-controlled epidural analgesia. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

A portable, disposable device for patient-controlled epidural analgesia following Caesarean section: evaluation by patients and nurses. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults. [2021]

4. India pubmed.ncbi.nlm.nih.gov

Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

[Continuous epidural perfusion with meperidine on demand for the treatment of postoperative pain]. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Epidural Needle Extension through the Ligamentum Flavum Using the Standard versus the CompuFlo®-Assisted Loss of Resistance to Saline Technique: A Simulation Study. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Experimental validation of the CompuFlo® epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Differentiating False Loss of Resistance from True Loss of Resistance While Performing the Epidural Block with the CompuFlo® Epidural Instrument. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Identification of the epidural space using pressure waveform analysis (CompuFlo® technology): a case series]. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Pressure monitoring devices may undetect epidural space: a report on the use of Compuflo® system for epidural injection. [2023]