Real-time Ultrasound Guidance for Thoracic Epidural Blocks

Sponsor
University of Chile (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05165498
Collaborator
(none)
100
1
7
14.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Real-time ultrasound guidance for thoracic epidural catheter placement.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Reliability of Real-time Ultrasound Guidance as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.
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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of successful epidural blocks after US-guided insertion of epidural catheters [15 minutes after the local anesthetic injection through the epidural catheter]

    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.

Secondary Outcome Measures

  1. Number of blocked dermatomes [15 minutes after the local anesthetic injection through the epidural catheter]

    Number of blocked dermatomes after injection of local anesthetics through the epidural catheter.

  2. Localization of blocked dermatomes [15 minutes after the local anesthetic injection through the epidural catheter]

    Localization of blocked dermatomes after injection of local anesthetics through the epidural catheter.

  3. Image time [Up to 30 minutes after skin disinfection]

    Needed time (minutes and seconds) to obtain an adequate image of the interlaminar space

  4. Needle time [Up to 30 minutes after skin disinfection]

    Needed time (minutes and seconds) to insert the Tuohy needle tip in the interlaminar space and confirm a loss of resistance

  5. Catheter installation time [Up to 30 minutes after skin disinfection]

    Elapsed time (minutes and seconds) from loss of resistance acquisition until the catheter is secured

  6. Block performance time [Up to 30 minutes after skin disinfection]

    Time (minutes and seconds) between skin disinfection and once the catheter is secured in place.

  7. Epidural block-related complications [Up to 30 minutes after skin disinfection]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clínico Universidad de Chile Santiago Metropolitan Chile 8380456

Sponsors and Collaborators

  • University of Chile

Investigators

  • Principal Investigator: Julián Aliste, MD, University of Chile

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Julian Aliste, Assistant Professor, University of Chile
ClinicalTrials.gov Identifier:
NCT05165498
Other Study ID Numbers:
  • OAIC 1037/19
First Posted:
Dec 21, 2021
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Julian Aliste, Assistant Professor, University of Chile
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022