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CompletedNCT05538884Updated May 3, 2024

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

An interventional study of Intertransverse process block in Intertransverse Process Block, Thoracic Nerve Block and Thoracic Paravertebral Block, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by Mahidol University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Intertransverse Process Block
  • Thoracic Nerve Block
  • Thoracic Paravertebral Block

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Keywords

  • MRI study
  • Volunteer study
03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's enrollment of 10 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy Thai men with no diseases

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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

Interventions

  • ProcedureIntertransverse 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.

06

What researchers measure

Primary outcomes

  1. Local anesthetic spreading from MRI image

    Using local anesthetic mixed with contrast

    Time frame: 1 month

07

Study locations

1 site
  • Siriraj hospital
    Bangkok, 10700, Thailand
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05538884
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
May 3, 2024
Start date
Oct 3, 2022
Primary completion
Oct 7, 2022
Completion
Oct 15, 2022
Last update
May 3, 2024

Study contacts

Pawinee Pangthipampai
principal investigator · Siriraj Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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