"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization"
NCT Number: NCT06556836
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Open Abdominal Surgery|Epidural Analgesia
Interventions: DEVICE: Doppler color and M-Mode ultrasound|DEVICE: Epidurography
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2025-03-30
Locations: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, Cdmx, 14080, Mexico

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.

Primary Outcome Measures: Diagnostic accuracy of ultrasound color Doppler compared to epidurography for localizing the catheter in the epidural space., Ultrasound Doppler Mode: To assess whether the color mosaic between the posterior and anterior complexes is observed when saline solution is administered through the catheter, indicating correct placement within the epidural space.

Epidurography: Performed by an interventional pain specialist and a radiologist, it will confirm whether the catheter is correctly positioned inside or outside the epidural space.

Diagnostic Accuracy of Ultrasound: Evaluated by comparing the findings from Doppler mode and M-mode (color mosaic and granular pattern) with the results of epidurography (inside or outside the epidural space)., 15 minutes|Diagnostic accuracy of ultrasound Mode M compared to epidurography for localizing the catheter in the epidural space., Ultrasound M-Mode: To detect a granular or undulating pattern when intermittent boluses of saline solution are administered through the epidural catheter, which indicates correct placement within the epidural space., 15 minutes
Secondary Outcome Measures: Pain Relief Effectiveness, At 24 hours postoperatively, patients will complete an internationally validated and standardized questionnaire to assess static and dynamic pain intensity. This questionnaire includes 13 questions that evaluate various aspects of the patient's experience. These aspects include static and dynamic pain, adverse effects, anxiety, overall pain, perception of care, satisfaction, and history of chronic pain., 10 to 15 minutes|Sensory Assessment Level of Abdominal Wall:, Assessment Technique: Utilize a standardized method, such as a pinprick test, cotton swab, or temperature sensation test, to evaluate sensory responses across different regions of the abdominal wall, 5 minutes