"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization"
"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization in Patients Undergoing Open Abdominal Surgery"
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
50 participants
Aug 15, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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
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Interventions
A diagnostic test intervention using color Doppler and M-Mode ultrasound will be conducted to localize the catheter within the epidural space and compared with epidurography.
An epidurography is an imaging procedure used to visualize the epidural space of the spine. The process involves inserting an epidural catheter, through which a contrast dye is injected. Fluoroscopy or X-rays are then used to capture real-time images of the contrast flow, helping to ensure the catheter's correct placement and to detect any localization anomalies. In this study, the epidurography will be performed in the radiology department by a radiologist and a pain management interventionist.
Locations(1)
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NCT06556836