CompletedNot Applicable

"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization"

Mexico66 participantsStarted 2024-08-22

Plain-language summary

The goal of this clinical trial is to evaluate the effectiveness of ultrasound for locating epidural catheters compared to the gold standard, epidurography. This study is focused on patients undergoing major open abdominal surgeries, who often experience moderate to severe pain during the first 24 to 48 hours after surgery. The main questions it aims to answer are: How does the accuracy of ultrasound for detecting epidural catheter placement compare to that of epidurography? Can ultrasound provide a reliable alternative to epidurography in surgical settings where epidurography is not feasible? In this trial, participants will: Undergo a standard epidural analgesia procedure for pain management during their surgery. Have their epidural catheter placement checked using both ultrasound and epidurography. Report their pain levels and any issues with pain control during the immediate postoperative period. The study will assess whether ultrasound can effectively replace epidurography in confirming catheter placement, potentially offering a less invasive and more practical solution in routine surgical environments.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 years or older * Provided informed consent * Scheduled for major open abdominal surgery that necessitates epidural analgesia * Capable of completing the PAIN OUT questionnaire Exclusion Criteria: * Contraindications to epidural analgesia * Communication or cognitive impairments that prevent understanding or completing the questionnaire * Neurological disorders that affect sensory or motor function * Critical illness or unstable medical conditions * Use of anticoagulants * Advanced liver cirrhosis * Certain specific surgical procedures where epidural analgesia is contraindicated or not applicable * Allergy to contrast agent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic accuracy of ultrasound color Doppler compared to epidurography for localizing the catheter in the epidural space.

Timeframe: 15 minutes

Diagnostic accuracy of ultrasound Mode M compared to epidurography for localizing the catheter in the epidural space.

Timeframe: 15 minutes

Trial details

NCT IDNCT06556836

SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-15

View on ClinicalTrials.gov More Open Abdominal Surgery trials