ITP Block: Single or Multiple Injection? - Trial NCT05753397

Timeline & Enrollment

Primary Outcome

Anesthetized thoracic dermatomes.

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.

ICD-10 Classifications