Real-time Ultrasound Guidance for Thoracic Epidural Blocks

Reliability of Real-time Ultrasound Guidance as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks

Various modalities have been proposed for real-time confirmation of loss of resistance (LOR) for thoracic epidural blocks. With real-time ultrasound (US) guidance, the anesthesiologist attempts to visualize the sonographic advancement of the epidural needle and penetration of the epidural space (as detected by LOR)

This observational study is set out to confirm the reliability of real-time ultrasound guidance as an adjunct to LOR for thoracic epidural blocks.

Study Overview

• Status: Not yet recruiting
• Conditions: Analgesia; Rib Fractures; Thoracic Tumors; Abdomen Tumors
• Intervention / Treatment: Procedure: Real-time ultrasound guidance for thoracic epidural catheter placement.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Julián Aliste, MD; Phone Number: +56229788221; Email: julian.aliste@uchile.cl

Study Locations

• Chile
  • Metropolitan
    • Santiago, Metropolitan, Chile, 8380456
      • Hospital Clinico Universidad de Chile
      • Contact: Julián Aliste, MD; Phone Number: +56229788221; Email: julian.aliste@uchile.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective thoracic surgery, abdominal surgery, or suffering from rib fractures who will have placed a thoracic epidural catheter to manage their perioperative analgesia.

Description

Inclusion Criteria:

• Age between 18 and 80 years
• American Society of Anesthesiologists classification 1-3
• Body mass index between 20 and 35 (kg/m2)

Exclusion Criteria:

• Adults who are unable to give their own consent
• Sepsis (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. leukocytosis, increased c-reactive protein, increased procalcitonin)
• Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
• Allergy to local anesthetics (LAs)
• Prior surgery in the thoracic spine

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients undergoing elective thoracic surgery, abdominal surgery, or having rib fractures; Patients undergoing elective thoracic surgery, abdominal surgery, or having rib fractures who will have placed a thoracic epidural catheter to manage their perioperative analgesia.

Procedure: Real-time ultrasound guidance for thoracic epidural catheter placement.; With an US-guided parasagittal oblique approach, the interlaminar space at the union between laminas and spinous processes at the predefined insertion level will be identified. A skin wheal will be raised with 3 mL of lidocaine 1%. Afterward, an 18-gauge Tuohy epidural block needle will be advanced under direct US vision until the tip is insinuated between the laminas and anchored to the flavum ligament. Then the needle will be attached to a low resistance syringe prefilled with saline solution and advanced until LOR to injection is confirmed. Then a 20-Gauge epidural catheter will be inserted 3-5 cm beyond the needle tip inside the epidural space and the needle removed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of successful epidural blocks after US-guided insertion of epidural catheters	After fifteen minutes of local anesthetic administration (4- mL dose of lidocaine 2% with epinephrine 5 μg/mL ), an investigator will apply ice to the T1 to L4 dermatomes bilaterally. The criterion standard for success will be the presence of an epidural block, defined as a block to ice in at least 2 dermatomes bilaterally. If operators could not advance the catheter past the needle tip after 2 attempts despite a 180-degree rotation of the bevel between the first and second attempts, epidural blocks will be considered failures.	15 minutes after the local anesthetic injection through the epidural catheter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of blocked dermatomes	Number of blocked dermatomes after injection of local anesthetics through the epidural catheter.	15 minutes after the local anesthetic injection through the epidural catheter
Localization of blocked dermatomes	Localization of blocked dermatomes after injection of local anesthetics through the epidural catheter.	15 minutes after the local anesthetic injection through the epidural catheter
Image time	Needed time (minutes and seconds) to obtain an adequate image of the interlaminar space	Up to 30 minutes after skin disinfection
Needle time	Needed time (minutes and seconds) to insert the Tuohy needle tip in the interlaminar space and confirm a loss of resistance	Up to 30 minutes after skin disinfection
Catheter installation time	Elapsed time (minutes and seconds) from loss of resistance acquisition until the catheter is secured	Up to 30 minutes after skin disinfection
Block performance time	Time (minutes and seconds) between skin disinfection and once the catheter is secured in place.	Up to 30 minutes after skin disinfection
Epidural block-related complications	Incidence of adverse events related to epidural block or local anesthetic injection (i.e. paresthesia, accidental dural puncture, intravascular or subarachnoid position of catheters, intravascular, subarachnoid or subdural injection, local anesthetic systemic toxicity)	Up to 30 minutes after skin disinfection

Collaborators and Investigators

• Sponsor: University of Chile
• Investigators: Principal Investigator: Julián Aliste, MD, University of Chile

Publications and helpful links

General Publications

• Tran DQ, Gonzalez AP, Bernucci F, Finlayson RJ. Confirmation of loss-of-resistance for epidural analgesia. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):166-73. doi: 10.1097/AAP.0000000000000217. No abstract available.
• Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.
• Tran DQ, Van Zundert TC, Aliste J, Engsusophon P, Finlayson RJ. Primary Failure of Thoracic Epidural Analgesia in Training Centers: The Invisible Elephant? Reg Anesth Pain Med. 2016 May-Jun;41(3):309-13. doi: 10.1097/AAP.0000000000000394.
• Arnuntasupakul V, Van Zundert TC, Vijitpavan A, Aliste J, Engsusophon P, Leurcharusmee P, Ah-Kye S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Conventional and Waveform-Confirmed Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2016 May-Jun;41(3):368-73. doi: 10.1097/AAP.0000000000000369.
• Elgueta MF, Duong S, Finlayson RJ, Tran DQ. Ultrasonography for neuraxial blocks: a review of the evidence. Minerva Anestesiol. 2017 May;83(5):512-523. doi: 10.23736/S0375-9393.16.11650-5. Epub 2016 Nov 9.
• Pak DJ, Gulati A. Real-Time Ultrasound-Assisted Thoracic Epidural Placement: A Feasibility Study of a Novel Technique. Reg Anesth Pain Med. 2018 Aug;43(6):613-615. doi: 10.1097/AAP.0000000000000761.
• Yeager MP, Bae EE, Parra MC, Barr PA, Bonham AK, Sites BD. Fluoroscopy-assisted epidural catheter placement: an exploratory analysis of 303 pre-operative epidurograms. Acta Anaesthesiol Scand. 2016 Apr;60(4):513-9. doi: 10.1111/aas.12649. Epub 2015 Oct 28.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound-guided; Thoracic peridural
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Thoracic Neoplasms; Rib Fractures
• Other Study ID Numbers: OAIC 1037/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No