- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05235815
Ultrasound- Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block
Ultrasound-Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block: Description of Sonoanatomy, Technique and Block Dynamics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During a TPVB the LA is injected into the paravertebral space adjacent to the thoracic vertebra and close to the intervertebral foramen. Traditionally, either landmark or ultrasound-guided, TPVB is performed by depositing the LA anterior to the superior costotransverse ligament (SCTL), i.e. the block needle typically pierces the SCTL to reach the wedge-shaped TPVB space. Although it is a safe technique, the needle tip comes close to the pleura during the injection, therefore, increasing the potential for pleural puncture and pneumothorax, especially when performed by inexperienced physicians.
Recently, with the help of 3D micro computer tomography (CT), Cho T and colleagues have demonstrated in cadavers that the medial part of the SCTL does not end at the base of the transverse process but extends anteriorly to the vertebral body dividing the wedge-shaped paravertebral space into a retro SCTL compartment (posterior to SCTL) and a true paravertebral space (anterior to SCTL). Also, they demonstrated that the SCTL, as it extends to the vertebral body, forms a medial slit near the intervertebral foramen through which the ventral rami enters the true paravertebral space. Furthermore, they highlighted that the retro SCTL space or compartment is in direct communication with the intervertebral foramen and epidural space medially and to the true paravertebral space (through the medial and lateral slits). It is evident from their study that the retro SCTL compartment contains both the divisions of the spinal nerve, i.e., the ventral and dorsal rami, the latter exits the compartment to enter the erector spinae plane. Hence, with this new concept, it appears that the block needle tip needs not to pierce the SCTL as required in a conventional TPVB and LA deposited at the retro SCTL compartment, theoretically can spread to the paravertebral space, intervertebral foramen and the epidural space, to block the spinal nerves and its divisions, and the sympathetic trunks. The investigators believe that the LA injection in the retro SCTL compartment, owing to its close relationship with the intervertebral foramen, thoracic spinal nerve, and the sympathetic trunks, will also produce rapid onset of ipsilateral and or bilateral segmental somatic and sympathetic blockade of the thoracic dermatomes, akin to TPVB. In addition, as the needle tip lies farther away from the pleura (posterior to SCTL) the investigators believe that this technique may also be safer in terms of the potential risk of pleural puncture or pneumothorax than a conventional TPVB.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- Prince of Wales Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Phase 1: Healthy volunteers of age 18-60 years
- Phase 2: Patients age 18-80 years scheduled for video assisted thoracoscopic surgery (VATS)
Exclusion Criteria:
- Phase 2: 1. Patient refusal 2. Local skin site infection 3. Coagulopathy 4. History of allergy to local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sonoanatomy and retro SCTL compartment block
During phase 1, ten healthy human volunteers will be involved. A bilateral ultrasound scan will be performed in the paravertebral region to describe the sonoanatomy of the retro SCTL compartment. During phase 2, participants who are scheduled for video-assisted thoracoscopic surgery (VATS) will receive an ultrasound-guided multi-level (T3-4, T5-6 and T7-8) retro SCTL compartment block. |
For phase 1, healthy human volunteers will be positioned in the lateral position with the side to be scanned in the non-dependent position. An ultrasound scan sequence to describe the retro SCTL space will be performed on both sides. During phase 2, participants who are scheduled for video-assisted thoracoscopic surgery (VATS) will receive an ultrasound-guided multi-level (T3-4, T5-6 and T7-8) retro SCTL compartment block. After positioning the participants, cleaning and draping the injection site, under sterile aseptic precautions and local anaesthetic infiltration, the block needle is inserted at the corresponding vertebral level (T7-T8) under ultrasound guidance in-plane to the ultrasound beam. Once the needle tip reaches the lateral aspect of the inferior articular process and behind the SCTL ligament, the desired volume (6ml/each level) of LA will be injected. This process will be continued at the remaining two vertebral levels (T5-T6 and T3-T4). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound visualization of the retro SCTL compartment in volunteers
Time Frame: Within 30 minutes after entering the procedure room
|
The following structures will be assessed:
The quality of ultrasound visibility (ultrasound visibility score, UVS) of each structure will be assessed using a 4-point Likert scale (0= not visible, 1= hardly visible, 2= well visible, 3= very well visible). |
Within 30 minutes after entering the procedure room
|
|
Readiness for surgery
Time Frame: Within 30 minutes after the block at 5 minutes interval
|
An overall sensory score of =<30 on the ipsilateral hemithorax (loss of sensation to cold stimulus (ice cube), NRS: 0-100, 0= no sensation, 100= normal sensation) Sensation block assessment: T2-L5 spinal nerves |
Within 30 minutes after the block at 5 minutes interval
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Block performance time
Time Frame: Within 30 minutes after entering the procedure room
|
The time taken from the start of the local anaesthetic (LA) skin infiltration to the end of the LA injection for the block.
|
Within 30 minutes after entering the procedure room
|
|
Complete sensory block
Time Frame: Within 30 minutes after the block at 5 minutes interval
|
An overall sensory score 0 on the ipsilateral hemithorax (loss of sensation to cold stimulus (ice cube), NRS: 0-100, 0= no sensation, 100= normal sensation) Sensation block assessment: T2-L5 spinal nerves |
Within 30 minutes after the block at 5 minutes interval
|
|
Total amount of vasopressor used
Time Frame: After completion of the block and through the surgical period, an average of 6 hours
|
The total amount of vasopressor requirements after the completion of the block and through the surgical period will be recorded.
|
After completion of the block and through the surgical period, an average of 6 hours
|
|
Total amount of morphine used
Time Frame: During surgical period and postanesthesia care unit (PACU) period, an average of 6 hours
|
The total amount of morphine requirements through the surgical period and post anaesthesia care unit (PACU) period, until the discharge of participants from the PACU, will be recorded.
|
During surgical period and postanesthesia care unit (PACU) period, an average of 6 hours
|
|
Postoperative pain score
Time Frame: At arrival and discharge from postanesthesia care unit (PACU)
|
Postoperative pain score in the form of a numerical rating scale (NRS) will be recorded in the post anaesthesia care unit (PACU) at rest and movement (cough), at arrival and discharge from PACU. (NRS: 0-100, 0= no pain, 100= worst imaginable pain) |
At arrival and discharge from postanesthesia care unit (PACU)
|
|
Postoperative sensory score before discharge
Time Frame: At discharge from postanesthesia care unit (PACU)
|
Sensory score on bilateral hemithorax (loss of sensation to a cold stimulus (ice cube), NRS: 0-100, 0= no sensation, 100= normal sensation), when discharge from postanesthesia care unit (PACU). Sensation block assessment: T2-L5 spinal nerves |
At discharge from postanesthesia care unit (PACU)
|
|
Complications
Time Frame: Within 45 minutes after the block, within 24 hours post surgery and at 1 week after the surgery
|
Any complication directly related to the retro SCTL compartment block (vascular puncture, pleural puncture, or local anaesthetic toxicity) will be recorded.
|
Within 45 minutes after the block, within 24 hours post surgery and at 1 week after the surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Manoj K Karmakar, MD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Retro SCTL Block ver3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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