Clinical trial NCT05165498: Real-time Ultrasound Guidance for Thoracic Epidural Blocks
Official title: Reliability of Real-time Ultrasound Guidance as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Analgesia
Thoracic Tumors
Abdomen Tumors
Rib Fractures
Keywords: Thoracic peridural
Ultrasound-guided
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of successful epidural blocks after US-guided insertion of epidural catheters
timeFrame: 15 minutes after the local anesthetic injection through the epidural catheter
Secondary outcomes:
measure: Number of blocked dermatomes
timeFrame: 15 minutes after the local anesthetic injection through the epidural catheter
measure: Localization of blocked dermatomes
timeFrame: 15 minutes after the local anesthetic injection through the epidural catheter
measure: Image time
timeFrame: Up to 30 minutes after skin disinfection
measure: Needle time
timeFrame: Up to 30 minutes after skin disinfection
measure: Catheter installation time
timeFrame: Up to 30 minutes after skin disinfection
measure: Block performance time
timeFrame: Up to 30 minutes after skin disinfection
measure: Epidural block-related complications
timeFrame: Up to 30 minutes after skin disinfection
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Metropolitan
Study officials:
affiliation: University of Chile
name: Julián Aliste, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.