Intertransverse Process BlockNCT05538884
A Novel Intertransverse Plane Block: a Magnetic Resonance Imaging and Volunteer Study
A study testing Intertransverse process block in people with Intertransverse Process Block and Thoracic Nerve Block, run by Mahidol University at 1 site in Thailand.
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intertransverse Process Block, Thoracic Nerve Block, Thoracic Paravertebral Block
- What is being tested?
- Intertransverse process block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 3 Oct 2022to 15 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy Thai men with no diseases
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Being tested
- Intertransverse process block
- Keywords
- MRI study, Volunteer study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intertransverse process blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intertransverse process block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local anesthetic spreading from MRI image
Using local anesthetic mixed with contrast
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start3 Oct 2022
- Primary completion7 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertransverse Process BlockStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pawinee Pangthipampai, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538884
- Sponsor's protocol ID
- Si 267/2022
- Status last verified
- May 2024
- First submitted
- 11 Sep 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Intertransverse Plane Block: A Magnetic Resonance Imaging and Volunteer Study
- ClinicalTrials.gov ID
- NCT05538884
- Acronym / sponsor ID
- Si 267/2022
- Keywords
- MRI study, Volunteer study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 3 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intertransverse process block | Experimental | Procedure: Intertransverse process blockUsing 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy Thai men with no diseases
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intertransverse process blockThe 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. | Procedure or surgery | Intertransverse process block |
Primary outcome
Local anesthetic spreading from MRI image
Time frame: 1 month
Using local anesthetic mixed with contrast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawinee Pangthipampai principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intertransverse process block in people with Intertransverse Process Block and Thoracic Nerve Block, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local anesthetic spreading from MRI image (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.