A Novel Intertransverse Plane Block: a Magnetic Resonance Imaging and Volunteer Study

Intertransverse process block (ITPB) is a thoracic nerve block technique where the LA is injected into the thoracic "intertransverse tissue complex" posterior to the superior costotransverse ligament (SCTL). It may be an attractive alternative to a TPVB for unilateral surgery on the thorax, when considering the risk for pleural puncture, since it does not require direct needle access to the thoracic paravertebral space. However, although ITPB is ultrasound guided, the LA is frequently injected using surrogate bony landmarks in the sagittal sonogram, and in most cases without even identifying the SCTL.

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Key information

Conditions

Intertransverse Process Block Thoracic Nerve Block Thoracic Paravertebral Block

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj hospital

Bangkok, 10700, Thailand

About this study

The knowledge regarding the spread of local anesthetic is a major prerequisite for a safe and effective use of all regional anesthetic methods in clinical practice. The primary outcome is the spread of injectate which will be evaluated on axial three-dimensional MRI with contrast medium. The secondary outcome is the sensory dermatomal blockade of this novel ITPB block.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

healthy Thai men with no diseases

Exclusion criteria

inability to cooperate or communicate in Thai
BMI ≥ 30 kg/m2 or body weight ≤ 45 kgs
allergy to local anesthetics or contrast agents
infection in the block area
previous surgery or anatomical abnormalities of thoracic spines closed to block area
coagulation disorder/thrombocytopenia/anticoagulation therapy
contraindications to magnetic resonance imaging (MRI) (metal implants - pacemaker and others, claustrophobia)

Treatment and study plan

Intertransverse Process Block

Procedure

The ITPB block at T5-6 will be performed with a mixture of local anesthetic with MRI contrast 0.5% bupivacaine 10 ml and 0.5 ml contrast in concentration 3.09 mmol/l. Volunteers will be moved to MRI machine and imaged in a supine position for their whole thoracic spine. This process will last about 45-60 minutes.

Primary outcomes

Local anesthetic spreading from MRI image

Time frame: 1 month

Using local anesthetic mixed with contrast

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: May 3, 2024
Registry last updated: May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed