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
1 other identifier
interventional
30
1 country
1
Brief Summary
Thoracic paravertebral block (TPVB) is a regional anaesthetic technique that produces ipsilateral, segmental, somatic and sympathetic nerve blockade of multiple contiguous thoracic dermatomes. 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. With the recently described retro superior costotransverse ligament (SCTL) compartment (using MRI) which has been shown to be in direct continuity with the intervertebral foramen, the investigators propose that the block needle need not pierce the SCTL and lie close to the pleura but can be positioned safely behind the ligament to deposit the local anaesthetic (LA). Therefore, this study aims to describe the sonoanatomy of the retro SCTL compartment and evaluate the block injection technique and sensory dynamics in patients scheduled for video-assisted thoracoscopic surgery (VATS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 11, 2022
CompletedStudy Start
First participant enrolled
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2024
CompletedApril 16, 2024
April 1, 2024
1.8 years
January 20, 2022
April 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ultrasound visualization of the retro SCTL compartment in volunteers
The following structures will be assessed: 1. The SCTL, 2. The medial extension of SCTL in front of the intervertebral foramen, 3. The retro SCTL compartment behind the medial extension of the SCTL, and 4. The true paravertebral space. 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
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 Outcomes (7)
Complete sensory block
Within 30 minutes after the block at 5 minutes interval
Block performance time
Within 30 minutes after entering the procedure room
Total amount of vasopressor used
After completion of the block and through the surgical period, an average of 6 hours
Total amount of morphine used
During surgical period and postanesthesia care unit (PACU) period, an average of 6 hours
Postoperative pain score
At arrival and discharge from postanesthesia care unit (PACU)
- +2 more secondary outcomes
Study Arms (1)
Sonoanatomy and retro SCTL compartment block
EXPERIMENTALDuring 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Phase 1: Healthy volunteers of age 18-60 years
- Phase 2: Patients age 18-80 years scheduled for video assisted thoracoscopic surgery (VATS)
You may not qualify if:
- Phase 2: 1. Patient refusal 2. Local skin site infection 3. Coagulopathy 4. History of allergy to local anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, Hong Kong
Study Officials
- PRINCIPAL INVESTIGATOR
Manoj K Karmakar, MD
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 20, 2022
First Posted
February 11, 2022
Study Start
May 17, 2022
Primary Completion
March 13, 2024
Study Completion
March 20, 2024
Last Updated
April 16, 2024
Record last verified: 2024-04