NCT05753397

ITP Block: Single or Multiple Injection?

Status unknown Phase 4 Last updated 3 March 2023

What this trial tests

Phase 4 trial testing Ropivacaine injection in Anesthesia, Local in 12 participants. Status unknown.

Timeline

26 February 2023

Primary endpoint
5 March 2023

5 March 2023

Quick facts

Lead sponsor	Zealand University Hospital
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	12
Start date	26 February 2023
Primary completion	5 March 2023
Estimated completion	5 March 2023
Sites	1 location across Denmark

Drugs / interventions tested

• Ropivacaine injection — full drug profile →

Conditions studied

• Anesthesia, Local — all drugs for Anesthesia, Local →

Sponsor

Zealand University Hospital

Who can join

Adults 18 to 99, male only, with Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.