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

May 1, 2024 updated by: Mahidol University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local anesthetic spreading from MRI image
Time Frame: 1 month
Using local anesthetic mixed with contrast
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Pawinee Pangthipampai, Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2022

Primary Completion (Actual)

October 7, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

September 11, 2022

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 267/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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