NCT05235815

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

May 17, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

1.8 years

First QC Date

January 20, 2022

Last Update Submit

April 14, 2024

Conditions

Keywords

Superior costotransverse ligamentVideo assisted thoracoscopic surgeryThoracic paravertebral blockRetro superior costotransverse ligament compartment

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

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.

Procedure: 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).

Sonoanatomy and retro SCTL compartment block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Manoj K Karmakar, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

Locations