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

NCT ID: NCT05538884

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-03
• Study Completion Date: 2022-10-15

Brief Summary

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.

Detailed Description

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.

Conditions

Intertransverse Process Block; Thoracic Nerve Block; Thoracic Paravertebral Block

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Intertransverse process block

Using a simple transverse ultrasound imaging technique to visualize the superior costotransverse ligament (SCTL) and the retro-SCTL space, we can perform a novel ITPB. Local anesthetic will be injected at the retro SCTL space.

Group Type: EXPERIMENTAL

Intertransverse process block

Intervention Type: 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.

Interventions

Intertransverse process block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pawinee Pangthipampai

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Siriraj hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

Si 267/2022

Identifier Type: -

Identifier Source: org_study_id