Ultrasound- Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block

Thoracic Surgery, Video-Assisted Clinical Trial

Official title:

Ultrasound-Guided Retro Superior Costotransverse Ligament (SCTL) Compartment Block: Description of Sonoanatomy, Technique and Block Dynamics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05235815
• Other study ID #: Retro SCTL Block ver3
• Status: Completed
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 20, 2024
• Est. primary completion date: March 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Within 30 minutes after entering the procedure room
Primary	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	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	Within 30 minutes after the block at 5 minutes interval
Secondary	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.	Within 30 minutes after entering the procedure room
Secondary	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.	After completion of the block and through the surgical period, an average of 6 hours
Secondary	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.	During surgical period and postanesthesia care unit (PACU) period, an average of 6 hours
Secondary	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)	At arrival and discharge from postanesthesia care unit (PACU)
Secondary	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	At discharge from postanesthesia care unit (PACU)
Secondary	Complications	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