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

Thoracic Paravertebral Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05538884
• Other study ID #: Si 267/2022
• Status: Completed
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: October 15, 2022

Study information

• Verified date: May 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 15, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Dissection
• Thoracic Paravertebral Block

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local anesthetic spreading from MRI image	Using local anesthetic mixed with contrast	1 month