Real-time Ultrasound Guidance for Thoracic Epidural Blocks

NCT05165498 | Not Yet Recruiting DMC

• 1 other identifier: OAIC 1037/19
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia; Thoracic Tumors; Abdomen Tumors; Rib Fractures

Keywords

Thoracic peridural; Ultrasound-guided

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of blocked dermatomes

  15 minutes after the local anesthetic injection through the epidural catheter

• Localization of blocked dermatomes

  15 minutes after the local anesthetic injection through the epidural catheter

• Image time

  Up to 30 minutes after skin disinfection

• Needle time

  Up to 30 minutes after skin disinfection

• Catheter installation time

  Up to 30 minutes after skin disinfection

Study Arms (1)

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.

Interventions

Real-time ultrasound guidance for thoracic epidural catheter placement. PROCEDURE

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.

Patients undergoing elective thoracic surgery, abdominal surgery, or having rib fractures

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Metropolitan, 8380456, Chile

Location

Related Publications (7)

• 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.

  PMID: 27035462 BACKGROUND

• 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.

  PMID: 25642911 BACKGROUND

• 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.

  PMID: 26469364 BACKGROUND

• 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.

  PMID: 26894628 BACKGROUND

• 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.

  PMID: 27827521 BACKGROUND

• 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.

  PMID: 29553999 BACKGROUND

• 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.

  PMID: 26508378 BACKGROUND

MeSH Terms

Conditions

Agnosia; Abdominal Neoplasms; Rib Fractures

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Julián Aliste, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julián Aliste, MD

CONTACT

+56229788221; julian.aliste@uchile.cl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 21, 2021
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 14, 2023

Record last verified: 2023-12

Locations

CL (1)