Thoracic Surgery, Video-AssistedNCT05235815
Ultrasound- Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block
A study testing Retro SCTL compartment block in people with Thoracic Surgery, Video-Assisted, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Thoracic paravertebral block (TPVB) is a regional anaesthetic technique that produces ipsilateral, segmental, somatic and sympathetic nerve blockade of multiple contiguous thoracic dermatomes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thoracic Surgery, Video-Assisted
- What is being tested?
- Retro SCTL compartment block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 17 May 2022to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1: Healthy volunteers of age 18-60 years
- Phase 2: Patients age 18-80 years scheduled for video assisted thoracoscopic surgery (VATS)
Who cannot join
- Phase 2: 1. Patient refusal 2. Local skin site infection 3. Coagulopathy 4. History of allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block: Description of Sonoanatomy, Technique and Block Dynamics
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).
Read the 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.
- Conditions
- Thoracic Surgery, Video-Assisted
- Being tested
- Retro SCTL compartment block
- Keywords
- Superior costotransverse ligament, Video assisted thoracoscopic surgery, Thoracic paravertebral block, Retro superior costotransverse ligament compartment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retro SCTL compartment blockProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Sonoanatomy and retro SCTL compartment block | Experimental | 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. Receives: Procedure: Retro SCTL compartment block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound visualization of the retro SCTL compartment in volunteers
The following structures will be assessed:
- The SCTL,
- The medial extension of SCTL in front of the intervertebral foramen,
- The retro SCTL compartment behind the medial extension of the SCTL, and
- 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).
Measured: 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
Measured: Within 30 minutes after the block at 5 minutes interval
Secondary outcomes (7)
Complete sensory block
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
Measured: Within 30 minutes after the block at 5 minutes interval
Block performance time
The time taken from the start of the local anaesthetic (LA) skin infiltration to the end of the LA injection for the block.
Measured: Within 30 minutes after entering the procedure room
Total amount of vasopressor used
The total amount of vasopressor requirements after the completion of the block and through the surgical period will be recorded.
Measured: After completion of the block and through the surgical period, an average of 6 hours
Total amount of morphine used
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.
Measured: During surgical period and postanesthesia care unit (PACU) period, an average of 6 hours
Postoperative pain score
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)
Measured: At arrival and discharge from postanesthesia care unit (PACU)
Postoperative sensory score before discharge
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
Measured: At discharge from postanesthesia care unit (PACU)
Complications
Any complication directly related to the retro SCTL compartment block (vascular puncture, pleural puncture, or local anaesthetic toxicity) will be recorded.
Measured: Within 45 minutes after the block, within 24 hours post surgery and at 1 week after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start17 May 2022
- Primary completion13 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Surgery, Video-AssistedStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Manoj K Karmakar, Chinese University of Hong Kong
- Investigators
- Manoj K Karmakar, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235815
- Sponsor's protocol ID
- Retro SCTL Block ver3
- Status last verified
- Apr 2024
- First submitted
- 20 Jan 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block: Description of Sonoanatomy, Technique and Block Dynamics
- ClinicalTrials.gov ID
- NCT05235815
- Acronym / sponsor ID
- Retro SCTL Block ver3
- Conditions
- Thoracic Surgery, Video-Assisted
- Keywords
- Superior costotransverse ligament, Video assisted thoracoscopic surgery, Thoracic paravertebral block, Retro superior costotransverse ligament compartment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonoanatomy and retro SCTL compartment block | Experimental | Procedure: Retro SCTL compartment blockDuring 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Phase 1: Healthy volunteers of age 18-60 years
- Phase 2: Patients age 18-80 years scheduled for video assisted thoracoscopic surgery (VATS)
Key exclusion criteria (1 listed)
- Phase 2: 1. Patient refusal 2. Local skin site infection 3. Coagulopathy 4. History of allergy to local anesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retro SCTL compartment blockFor 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). | Procedure or surgery | Sonoanatomy and retro SCTL compartment block |
Primary outcome
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: 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).
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
7 secondary outcomes
Complete sensory block
Time frame: Within 30 minutes after the block at 5 minutes interval
Block performance time
Time frame: Within 30 minutes after entering the procedure room
Total amount of vasopressor used
Time frame: 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
Postoperative pain score
Time frame: At arrival and discharge from postanesthesia care unit (PACU)
Postoperative sensory score before discharge
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj K Karmakar, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retro SCTL compartment block in people with Thoracic Surgery, Video-Assisted, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound visualization of the retro SCTL compartment in volunteers (time frame: Within 30 minutes after entering the procedure room). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.