Real-time Ultrasound Guidance for Thoracic Epidural Blocks

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05165498
• Other study ID #: OAIC 1037/19
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: University of Chile
• Contact: Julián Aliste, MD
• Phone: +56229788221
• Email: julian.aliste[@]uchile.cl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdomen Tumors
• Analgesia
• Rib Fractures
• Thoracic Neoplasms
• Thoracic Tumors

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	Metropolitan

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Image time	Needed time (minutes and seconds) to obtain an adequate image of the interlaminar space	Up to 30 minutes after skin disinfection
Secondary	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
Secondary	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
Secondary	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
Secondary	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