Anesthesia, LocalPhase 4NCT05753397
ITP Block: Single or Multiple Injection?
A Phase 4 study testing Ropivacaine injection in people with Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The intertransverse process (ITP) block is a new ultrasound-guided peripheral nerve block modality designed for peri- and postoperative pain amelioration for patients undergoing surgery on the thoracic wall. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Feb 2023to 5 Mar 2023
- Phase
- Phase 4
- 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 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male sex Age ≥ 18 years at the date of inclusion American Associations of Anaesthesiologist (ASA) class I-II Have received thorough information, orally and in written form, and signed the "Informed Consent" form on participation in the study.
- Weight > 52,5 kilograms (chosen due to the international maximal single dose of Ropivacaine (3mg/kg))
Who cannot join
- Substantial co-morbidity: American Associations of Anaesthesiologist (ASA) class > II
- Inability to speak and understand Danish
- Inability to cooperate
- Allergy to study drugs
- Daily intake of analgesics (investigators decision)
- Alcohol and/or drug overuse (investigators decision)
Show all 14Show fewer
- Previous thoracic trauma or thoracic surgery
- Previous/current piercing of the nipple of any kind on blockade side
- Tattoos on the thorax (according to the investigators decision)
- Any systemic muscular or neuromuscular disease
- Any use of vasodilatory substance (investigators decision)
- Local infection at the site of injection or systemic infection
- Difficult sonoanatomical visualisation of the target area (SCTL, ITTC etc.) necessary for the block execution
- Severe hypovolemia
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde
Roskilde, Region Sjælland, 4000
Martin V Nielsen, MD, +4547325118, maven@regionsjaelland.dk
Jens N Børglum, PhD, MD, +4547325030, jedn@regionsjaelland.dk
About this study
Official title: The Intertransverse Process Block - Single or Multiple Injection? A Randomised, Procedure Related, Blinded Crossover Trial in Healthy Volunteers
The intertransverse process (ITP) block is a new ultrasound-guided peripheral nerve block modality designed for peri- and postoperative pain amelioration for patients undergoing surgery on the thoracic wall. The modality mimics the well-known thoracic paravertebral block but, potentially, with a significantly lower risk of adverse events. However, evidence for the ITP block efficacy and the clinical applicability, e.g. the number of injections, dermatomal coverage etc., is still sparse and needs further investigation.
In this noninferiority, short-term, randomised, blinded, procedure-related crossover trial we will further investigate the ITP block in healthy volunteers to see whether it is possible to reduce the number of injections from three to one and substantiate the number of anaesthetised dermatomes with either modality as the primary outcome. Secondary outcomes include sensory mapping of the thorax, non-invasive thermography, changes in non-invasive blood pressure and satisfaction with block application.
Read more
At Zealand University Hospital, twelve healthy volunteers will be randomised to receive either a single injection or multiple injection blockade with long-lasting local anaesthetic. All twelve participants will, on day one, receive active blockade with the well-known marketed drug Ropivacaine 7.5mg/ml, and all participants will receive 21 ml; that is six participants receiving 1x21ml and six participants receiving 3x7ml. The six participants receiving 1x21 ml will also receive two sham injections to ensure the blinding. No placebo is used. On day two the intervention is crossed over and the participants will receive the other modality. Within the following hour after block application, relevant standard cutaneous testing is performed; pinprick and cold sensation test for dermatomal coverage, the anaesthetised skin area is pen marked on the thorax and photo documented, thermography to measure temperature differences between each hemi thorax (blocked side vs. non- blocked side) and standard non-invasive blood pressure measurements are performed.
After 60 minutes of relevant testing the trial ends and the participant are free to leave the hospital 2 hours after block application if no adverse events are recorded. With such series of test procedures, we will generate new knowledge of the ITP block before future patients undergo breast cancer surgery.
- Conditions
- Anesthesia, Local
- Being tested
- Ropivacaine injection
- Keywords
- ultrasound guided nerveblock, Intertransverse Process Block, Healthy volunteers, Thoracic dermatomes, sensory mapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
We are testing if single injection Ropivacaine is non-inferior to multiple-injection Ropivacaine when applied within the intertransverse tissue complex (that is: a paraspinal application mimicking the paravertebral block)
| Study group | Role | What they receive |
|---|---|---|
| Single injection | Experimental | 1x21ml Ropivacaine (7.5mg/ml) at ITTC T4. Including two sham injections at ITTC T2 and ITTC T6 Receives: Drug: Ropivacaine injection |
| Multiple injection | Experimental | 3x7ml Ropivacaine (7.5mg/ml) at ITTC T2, T4 and T6. Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthetized thoracic dermatomes.
The primary outcome of this procedure related study is the number of anesthetized thoracic dermatomes.
Key points of sensory testing will follow International Standards for Neurological Classification of Spinal Cord Injury.
Dermatomal spread of the single- and multiple-injection ITP blocks will be determined using both mechanical (pinprick) and temperature (cold) discrimination, deficit for either modality is regarded as a sensory deficit.
Measured: Minute 35 post block application.
Secondary outcomes (4)
Sensory mapping.
The extent of cutaneous spread of the sensory block (single vs multiple-injection ITP block). Spread of the single- and multiple-injection ITP blocks respectively will be determined using both mechanical (pinprick) and temperature (cold) discrimination, deficit for either modality is regarded as a sensory deficit. Relevant areas are marked on the participants' thoraxes and transferred to paper for conversion to square centimeters.
Measured: Minute 45 post block application.
Thermography in a clinical setup.
A peripheral nerve block leads to a motor and somatosensory blockade but also sympathetic nerve fibers are being blocked. The following sympatholysis increases the diameter of the vessels (vasodilatation) in the skin and thereby increasing the blood flow and increases the temperature. Hence, it is possible that the technique would help determine the expected success of the blockade in a fast and efficient manner.
We will use the "Testo 883 Thermography camera" (Testo SE \& Co. KGaA, Lenzkirch, Baden-Württemberg, Germany) to obtain infrared imaging of the anterior thorax of the participants. Each thoracic dermatome from T2-T10 will be evaluated in the mid-clavicular line and reported as the temperature difference when compared to the contralateral side.
Measured: Minutes 10, 20 and 30 post block application
Non-invasive blood pressure.
Standard non-invasive blood pressure measurement reported as mean arterial pressure.
Measured: Minutes 15, 30 and 60 post block application.
Block application satisfaction.
The Numeric Rating Scale (NRS) for pain scores is a well-known clinical scale. It ranges 0-10, 0 being no pain and 10 being the worst pain imaginable.
The participant will rate the block application NRS score orally during block application.
Measured: During block application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start26 Feb 2023 (estimated)
- Primary completion5 Mar 2023 (estimated)
- Study completion5 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753397
- Sponsor's protocol ID
- ZUH-ITP-MBCS
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intertransverse Process Block - Single or Multiple Injection? A Randomised, Procedure Related, Blinded Crossover Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05753397
- Acronym / sponsor ID
- ZUH-ITP-MBCS
- Conditions
- Anesthesia, Local
- Keywords
- ultrasound guided nerveblock, Intertransverse Process Block, Healthy volunteers, Thoracic dermatomes, sensory mapping
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 26 Feb 2023 (estimated)
- Primary completion
- 5 Mar 2023 (estimated)
- Study completion
- 5 Mar 2023 (estimated)
- First posted
- 3 Mar 2023 (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.
The intertransverse process (ITP) block is a new ultrasound-guided peripheral nerve block modality designed for peri- and postoperative pain amelioration for patients undergoing surgery on the thoracic wall. The modality mimics the well-known thoracic paravertebral block but, potentially, with a significantly lower risk of adverse events. However, evidence for the ITP block efficacy and the clinical applicability, e.g. the number of injections, dermatomal coverage etc., is still sparse and needs further investigation.
In this noninferiority, short-term, randomised, blinded, procedure-related crossover trial we will further investigate the ITP block in healthy volunteers to see whether it is possible to reduce the number of injections from three to one and substantiate the number of anaesthetised dermatomes with either modality as the primary outcome. Secondary outcomes include sensory mapping of the thorax, non-invasive thermography, changes in non-invasive blood pressure and satisfaction with block application.
At Zealand University Hospital, twelve healthy volunteers will be randomised to receive either a single injection or multiple injection blockade with long-lasting local anaesthetic. All twelve participants will, on day one, receive active blockade with the well-known marketed drug Ropivacaine 7.5mg/ml, and all participants will receive 21 ml; that is six participants receiving 1x21ml and six participants receiving 3x7ml. The six participants receiving 1x21 ml will also receive two sham injections to ensure the blinding. No placebo is used. On day two the intervention is crossed over and the participants will receive the other modality. Within the following hour after block application, relevant standard cutaneous testing is performed; pinprick and cold sensation test for dermatomal coverage, the anaesthetised skin area is pen marked on the thorax and photo documented, thermography to measure temperature differences between each hemi thorax (blocked side vs. non- blocked side) and standard non-invasive blood pressure measurements are performed.
After 60 minutes of relevant testing the trial ends and the participant are free to leave the hospital 2 hours after block application if no adverse events are recorded. With such series of test procedures, we will generate new knowledge of the ITP block before future patients undergo breast cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single injection | Experimental | Drug: Ropivacaine injection1x21ml Ropivacaine (7.5mg/ml) at ITTC T4. Including two sham injections at ITTC T2 and ITTC T6 |
| Multiple injection | Experimental | Drug: Ropivacaine injection3x7ml Ropivacaine (7.5mg/ml) at ITTC T2, T4 and T6. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male sex Age ≥ 18 years at the date of inclusion American Associations of Anaesthesiologist (ASA) class I-II Have received thorough information, orally and in written form, and signed the "Informed Consent" form on participation in the study.
- Weight > 52,5 kilograms (chosen due to the international maximal single dose of Ropivacaine (3mg/kg))
Key exclusion criteria (14 listed)
- Substantial co-morbidity: American Associations of Anaesthesiologist (ASA) class > II
- Inability to speak and understand Danish
- Inability to cooperate
- Allergy to study drugs
- Daily intake of analgesics (investigators decision)
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 |
|---|---|---|
| Ropivacaine injectionWe are testing if single injection Ropivacaine is non-inferior to multiple-injection Ropivacaine when applied within the intertransverse tissue complex (that is: a paraspinal application mimicking the paravertebral block) | Drug | Multiple injection, Single injection |
Primary outcome
Anesthetized thoracic dermatomes.
Time frame: Minute 35 post block application.
The primary outcome of this procedure related study is the number of anesthetized thoracic dermatomes. Key points of sensory testing will follow International Standards for Neurological Classification of Spinal Cord Injury. Dermatomal spread of the single- and multiple-injection ITP blocks will be determined using both mechanical (pinprick) and temperature (cold) discrimination, deficit for either modality is regarded as a sensory deficit.
4 secondary outcomes
Sensory mapping.
Time frame: Minute 45 post block application.
Thermography in a clinical setup.
Time frame: Minutes 10, 20 and 30 post block application
Non-invasive blood pressure.
Time frame: Minutes 15, 30 and 60 post block application.
Block application satisfaction.
Time frame: During block application.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Local
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Recruiting
Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
Not yet recruiting
Posterior Pericapsular Deep-gluteal Block
Pain, Postoperative
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine injection in people with Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
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 2 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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 Denmark. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Vedel Nielsen, MD (004547325118, maven@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthetized thoracic dermatomes. (time frame: Minute 35 post block application.). 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 Mar 2023.