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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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05165498
Enrollment
0
Registered
2021-12-21
Start date
2027-07-01
Completion date
2028-12-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdomen Tumors, Analgesia, Rib Fractures, Thoracic Tumors

Keywords

Thoracic peridural, Ultrasound-guided

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.

Interventions

PROCEDUREReal-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.

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of successful epidural blocks after US-guided insertion of epidural catheters15 minutes after the local anesthetic injection through the epidural catheterAfter 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.

Secondary

MeasureTime frameDescription
Number of blocked dermatomes15 minutes after the local anesthetic injection through the epidural catheterNumber of blocked dermatomes after injection of local anesthetics through the epidural catheter.
Localization of blocked dermatomes15 minutes after the local anesthetic injection through the epidural catheterLocalization of blocked dermatomes after injection of local anesthetics through the epidural catheter.
Image timeUp to 30 minutes after skin disinfectionNeeded time (minutes and seconds) to obtain an adequate image of the interlaminar space
Needle timeUp to 30 minutes after skin disinfectionNeeded time (minutes and seconds) to insert the Tuohy needle tip in the interlaminar space and confirm a loss of resistance
Catheter installation timeUp to 30 minutes after skin disinfectionElapsed time (minutes and seconds) from loss of resistance acquisition until the catheter is secured
Block performance timeUp to 30 minutes after skin disinfectionTime (minutes and seconds) between skin disinfection and once the catheter is secured in place.
Epidural block-related complicationsUp to 30 minutes after skin disinfectionIncidence 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)

Countries

Chile

Contacts

PRINCIPAL_INVESTIGATORJulián Aliste, MD

University of Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026