Epidural Waveform Analysis for Epidurals

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Non-english, Incarceration, Pregnant, Minors, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new method called epidural waveform analysis (EWA) compared to the usual X-ray method for placing epidurals. EWA checks the pressure in the epidural space to confirm correct placement by identifying a specific heart rate pattern. People undergoing surgery and planning to receive a thoracic epidural at Dartmouth Hitchcock Medical Center may qualify for this study. The trial seeks to determine if EWA is as reliable as the traditional method currently in use. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance epidural placement techniques.

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 prior data suggests that epidural waveform analysis is safe for confirming epidural placement?

Research has shown that epidural waveform analysis (EWA) safely confirms correct epidural placement. Studies have found EWA to be a simple and low-cost method for checking epidural placement. EWA uses the same pressure measuring tools already employed for other purposes, such as checking blood pressure or brain pressure, ensuring the equipment is well-tested and safe.

Previous findings suggest that EWA results in fewer complications than traditional methods. Specifically, one study found the failure rate for epidural blocks was much lower with EWA, at just 2%, compared to 24% with the conventional method. This indicates that EWA is not only safe but also more effective in ensuring correct epidural placement, reducing the chance of complications. Overall, EWA is considered well-tolerated and carries a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method, Epidural Waveform Analysis (EWA), to confirm epidural access. Unlike the standard fluoroscopic confirmation, which uses X-rays to visualize the epidural space, EWA analyzes the waveform patterns of pressure changes. This approach could potentially offer a non-invasive, radiation-free alternative for confirming epidural placement. If successful, it may lead to safer and more accessible epidural procedures, reducing the need for fluoroscopy.

What evidence suggests that epidural waveform analysis is effective for confirming epidural placement?

Research has shown that epidural waveform analysis (EWA) can effectively confirm correct epidural placement. One study found that EWA accurately identifies correct placement, while another study highlighted EWA as a simple and low-cost method for checking epidural location. This trial will compare the accuracy of EWA to the gold standard of fluoroscopic confirmation (FC). The researchers hypothesize that FC is superior to EWA. However, EWA might not detect incorrect placements if pain relief is inadequate. Overall, early evidence supports EWA as a promising tool for confirming epidural access. ^{1 2 6 7 8}

Who Is on the Research Team?

Alexander Abess, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals who require an epidural, a type of anesthesia that blocks pain in a particular region of the body. Participants must be suitable candidates for both EWA and fluoroscopic guidance procedures.

Inclusion Criteria

English speaking

I am 18 years old or older.

I am scheduled for surgery at Dartmouth Hitchcock Medical Center.

Exclusion Criteria

Non-English speaking

Incarceration

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo both epidural waveform analysis and fluoroscopic confirmation for epidural placement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Waveform Analysis

Trial Overview The study aims to compare two methods used to confirm correct placement of an epidural: Epidural Waveform Analysis (EWA) and traditional fluoroscopic guidance. Patients will experience both techniques to see which one is more effective.

How Is the Trial Designed?

Group I: Study Cohort Experimental Treatment 1 Intervention

The primary objective of this study is to assess the accuracy with which epidural waveform analysis (EWA) can confirm epidural access in comparison to the gold standard of fluoroscopic confirmation (FC). Our hypothesis is that FC is superior to EWA. We will determine the Positive Predictive Value and Negative Predictive Value of EWA referenced to FC.Every participant enrolled in the study will be in the experimental arm and will undergo epidural waveform analysis and fluoroscopic confirmation of epidural access.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217457

Epidural Wave Form Analysis vs Fluoroscopic Guidance for ... Epidural waveform analysis as method to determine epidural access will be compared to fluoroscopic confirmation. What is the study measuring? Primary Outcome ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8216732/

Analysis of Epidural Waveform to Determine Correct ... Pulsatile pressure waveform recording with CCDDS through the epidural catheter resulted in high sensitivity and positive predictive value which can help the ...

3. asra.com asra.com/news-publications/asra-newsletter/newsletter-item/asra-news/2018/07/19/examining-advanced-modalities-for-thoracic-epidural-catheter-placement

Examining Advanced Modalities for Thoracic Epidural ... Epidural waveform analysis can provide a simple and low cost confirmation ... confirming the location of the thoracic epidural space. J ...

4. trial.medpath.com trial.medpath.com/clinical-trial/18d9155f9754969d/nct07217457-epidural-wave-fluoroscopic-guidance-thoracic-placement

Epidural Wave Form Analysis vs Fluoroscopic Guidance for ... The primary objective of this study is to compare the effectiveness of epidural waveform analysis (EWA) with fluoroscopic guidance for confirmation of ...

5. rapm.bmj.com rapm.bmj.com/content/26/4/337

Confirmation of Location of Epidural Catheters by ... In 8 patients with inadequate epidural analgesia, the EPWF measurement failed to show oscillations, and contrast collections were observed in the paraspinous ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6120568/

The impact of fluoroscopic confirmation of thoracic imaging ... The purpose of this study was to determine the rate of successful TEA catheter insertion into the epidural space using contrast fluoroscopy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468824X17300347

Identification and confirmation of the epidural space Conventional “blind” attempts can result in failure of epidural placement and serious complications, including peripheral nerve damage and dural puncture.

8. rapm.bmj.com rapm.bmj.com/content/41/3/368

A Randomized Comparison Between Conventional and ... Conclusions Compared with its conventional counterpart, EWA-confirmed LOR results in a lower failure rate for thoracic epidural blocks (2% vs 24%) in our ...