Real-time Ultrasound Guidance for Thoracic Epidural Blocks

Not yet recruiting

• Conditions: Analgesia; Thoracic Tumors; Abdomen Tumors; Rib Fractures
• Interventions: Procedure: Real-time ultrasound guidance for thoracic epidural catheter placement.

• Registration Number: NCT05165498
• Lead Sponsor: University of Chile

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-07
• Study First Posted: 2021-12-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14
• Study Start: 2024-07
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing elective thoracic surgery, abdominal surgery, or having rib fractures	Real-time ultrasound guidance for thoracic epidural catheter placement.	Patients undergoing elective thoracic surgery, abdominal surgery, or having rib fractures who will have placed a thoracic epidural catheter to manage their perioperative analgesia.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.
Image time	Up to 30 minutes after skin disinfection	Needed time (minutes and seconds) to obtain an adequate image of the interlaminar space
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
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.
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.
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)

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, Metropolitan, Chile