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

NCT05538884 | Completed

• 1 other identifier: Si 267/2022
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intertransverse Process Block; Thoracic Nerve Block; Thoracic Paravertebral Block

Keywords

MRI study; Volunteer study

Outcome Measures

Primary Outcomes (1)

• Local anesthetic spreading from MRI image

  Using local anesthetic mixed with contrast

  1 month

Study Arms (1)

Intertransverse process block

EXPERIMENTAL

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.

Procedure: Intertransverse process block

Interventions

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.

Intertransverse process block

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy Thai men with no diseases

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

Study Officials

• Pawinee Pangthipampai

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The ITPB block at T5-6 level 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.

Study Record Dates

• First Submitted: September 11, 2022
• First Posted: May 3, 2024
• Study Start: October 3, 2022
• Primary Completion: October 7, 2022
• Study Completion: October 15, 2022
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)