Analgesic Efficacy of the Infraspinatus-Teres Minor (ITM) Interfascial Plane Block After Shoulder Arthroscopy: A Simon's Two-Stage Design

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois

About this trial

The main study objective is to observe the ability of the ITM block to provide clinically acceptable pain control after elective shoulder arthroscopy as measured by pain scores and morphine consumption.

The secondary objectives are determining its trajectory of efficacy up to 24 hours by measure of pain scores, morphine consumption and side effects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients of any sex

Class ASAI-III

Patients 18 years of age or older

Scheduled for elective shoulder arthroscopy

Disqualifiers

Allergy to any of: ropivacaine, paracetamol, celecoxib, morphine, ondansetron or dexamethasone

Refusal or inability to give consent

Bleeding diathesis (according to HEMSTOP score)

Neurological deficit of the operative side

Trial design

Design model

Single group

Treatments tested in this trial

  • Infraspinatus-teres minor block

    Other intervention

    A fascial plane block of the posterior shoulder with an injection between the infraspinatus and teres minor muscle which will anesthetise the axillary and supraclavicular nerves.

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Analgesic efficacy

The binary primary endpoint is block success, requiring the two following criteria: 1. Early treatment success: defined as the absence of treatment failure during the initial 2 hours postoperatively. Treatment failure is defined as either the requirement for greater than or equal to 10 mg of intravenous morphine and a VAS pain score \>3, or a VAS pain score of greater than or equal to 7 at any time during this period. 2. Twenty-four-hour analgesic success: defined as a VAS pain score \<4 at 24 hours postoperatively while consuming no more than 30 mg of reserve oral morphine.

Time frame
At 2 hours postoperatively and at 24 hours postoperatively.

Secondary outcomes

Other outcomes

Sponsors and contacts

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