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

NCT06556836 | Completed FDA Device

• 1 other identifier: ANE-4596-23-25-1
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Open Abdominal Surgery; Epidural Analgesia

Keywords

epidural catheter localization; epidural analgesia; open abdominal surgery; diagnostic accuracy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain Relief Effectiveness

  10 to 15 minutes

• Sensory Assessment Level of Abdominal Wall:

  5 minutes

Interventions

Doppler color and M-Mode ultrasound DEVICE

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.

Epidurography DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of both sexes, aged 18 and over, who provide informed consent, scheduled for major open abdominal surgery requiring epidural analgesia at the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, will be approached for participation. Inclusion and exclusion criteria will be applied to identify eligible participants. Those who meet the criteria and provide informed consent will be enrolled in the study. The sample size will be adjusted to ensure that 50 patients are recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Tlalpan, Mexico City, 14080, Mexico

Location

Related Publications (8)

• Elsharkawy H, Sonny A, Govindarajan SR, Chan V. Use of colour Doppler and M-mode ultrasonography to confirm the location of an epidural catheter - a retrospective case series. Can J Anaesth. 2017 May;64(5):489-496. doi: 10.1007/s12630-017-0819-y. Epub 2017 Jan 10.

  PMID: 28074426 RESULT

• Riveros-Perez E, Albo C, Jimenez E, Cheriyan T, Rocuts A. Color your epidural: color flow Doppler to confirm labor epidural needle position. Minerva Anestesiol. 2019 Apr;85(4):376-383. doi: 10.23736/S0375-9393.18.13175-0. Epub 2018 Nov 22.

  PMID: 30482003 RESULT

• van den Bosch OFC, Gleicher Y, Arzola C, Siddiqui N, Downey K, Carvalho JCA. Color flow Doppler in spinal ultrasound: a novel technique for assessment of catheter position in labor epidurals. Reg Anesth Pain Med. 2022 Dec;47(12):775-779. doi: 10.1136/rapm-2022-103948. Epub 2022 Sep 7.

  PMID: 36215115 RESULT

• Coleman JR, Hartmann P, Kona M, Thiele RA, Salajegheh R, Hanson NA. Use of epidurography in the perioperative and acute pain setting. Reg Anesth Pain Med. 2022 Jul;47(7):445-448. doi: 10.1136/rapm-2021-103274. Epub 2022 Apr 20.

  PMID: 35443993 RESULT

• Hermanides J, Hollmann MW, Stevens MF, Lirk P. Failed epidural: causes and management. Br J Anaesth. 2012 Aug;109(2):144-54. doi: 10.1093/bja/aes214. Epub 2012 Jun 26.

  PMID: 22735301 RESULT

• Weiss R, Popping DM. Is epidural analgesia still a viable option for enhanced recovery after abdominal surgery. Curr Opin Anaesthesiol. 2018 Oct;31(5):622-629. doi: 10.1097/ACO.0000000000000640.

  PMID: 29994937 RESULT

• Garduno-Lopez AL, Acosta Nava VM, Castro Garces L, Rascon-Martinez DM, Cuellar-Guzman LF, Flores-Villanueva ME, Villegas-Sotelo E, Carrillo-Torres O, Vilchis-Samano H, Calderon-Vidal M, Islas-Lagunas G, Richard Chapman C, Komann M, Meissner W, Baumbach P, Zaslansky R. Towards Better Perioperative Pain Management in Mexico: A Study in a Network of Hospitals Using Quality Improvement Methods from PAIN OUT. J Pain Res. 2021 Feb 15;14:415-430. doi: 10.2147/JPR.S282850. eCollection 2021.

  PMID: 33623424 RESULT

• PAIN OUT Research Group Jena; Chinese PAIN OUT network; Dutch PAIN OUT network; Mexican PAIN OUT network; Serbian PAIN OUT network; Spanish PAIN OUT network; French PAIN OUT network; Italian PAIN OUT network; Swiss PAIN OUT network; Irish PAIN OUT network; Belgian PAIN OUT network; Zaslansky R. Status quo of pain-related patient-reported outcomes and perioperative pain management in 10,415 patients from 10 countries: Analysis of registry data. Eur J Pain. 2022 Nov;26(10):2120-2140. doi: 10.1002/ejp.2024. Epub 2022 Sep 26.

  PMID: 35996995 RESULT

Related Links

• Garduño-López AL,et al.Optimization of epidural analgesia: proposed protocol for evaluation with Doppler Ultrasound and M Mode for precise catheter localization.Rev Mex Anestesiol. 2024; 47 (4): 236-242. https://dx.doi.org/10.35366/116229

Study Officials

• ANA LILIA GARDUÑO-LOPEZ, M.Sc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

• GUSTAVO LUGO-GOYTIA, D.Sc

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator (MSc and MD)

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start: August 22, 2024
• Primary Completion: July 15, 2025
• Study Completion: August 30, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)