ITP Block: Single or Multiple Injection?

NCT05753397 | Unknown Phase 4 DMC

• 1 other identifier: ZUH-ITP-MBCS
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anesthesia, Local

Keywords

ultrasound guided nerveblock; Intertransverse Process Block; Healthy volunteers; Thoracic dermatomes; sensory mapping

Outcome Measures

Primary Outcomes (1)

• 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.

  Minute 35 post block application.

Secondary Outcomes (4)

• Sensory mapping.

  Minute 45 post block application.

• Thermography in a clinical setup.

  Minutes 10, 20 and 30 post block application

• Non-invasive blood pressure.

  Minutes 15, 30 and 60 post block application.

• Block application satisfaction.

  During block application.

Study Arms (2)

Single injection

EXPERIMENTAL

1x21ml Ropivacaine (7.5mg/ml) at ITTC T4. Including two sham injections at ITTC T2 and ITTC T6

Drug: Ropivacaine injection

Multiple injection

EXPERIMENTAL

3x7ml Ropivacaine (7.5mg/ml) at ITTC T2, T4 and T6.

Drug: Ropivacaine injection

Interventions

Ropivacaine injection DRUG

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)

Multiple injection; Single injection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight \> 52,5 kilograms (chosen due to the international maximal single dose of Ropivacaine (3mg/kg))

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Martin Vedel Nielsen, MD

CONTACT

004547325118; maven@regionsjaelland.dk

Jens Børglum, MD

CONTACT

004547325030; jedn@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 3, 2023
• Study Start: February 26, 2023
• Primary Completion: March 5, 2023
• Study Completion: March 5, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)