Real-time Ultrasound Guidance for Thoracic Epidural Blocks
NCT ID: NCT05165498
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-07-31
2026-12-31
Brief Summary
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This observational study is set out to confirm the reliability of real-time ultrasound guidance as an adjunct to LOR for thoracic epidural blocks.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists classification 1-3
* Body mass index between 20 and 35 (kg/m2)
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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University of Chile
OTHER
Responsible Party
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Julian Aliste
Assistant Professor
Principal Investigators
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Julián Aliste, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chile
Locations
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Hospital Clínico Universidad de Chile
Santiago, Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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Julián Aliste, MD
Role: primary
References
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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.
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.
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.
Other Identifiers
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OAIC 1037/19
Identifier Type: -
Identifier Source: org_study_id