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Not yet recruitingNCT07808008ITMUpdated Sep 11, 2026

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

An interventional study of Infraspinatus-teres minor block in Pain After Shoulder Surgery, sponsored by Centre Hospitalier Universitaire Vaudois. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Centre Hospitalier Universitaire Vaudois · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Significant post-operative pain follows shoulder arthroscopy. Currently the interscalene brachial plexus (ISB) block is recommended as the first-choice regional anaesthesia technique (1). However, interscalene bloc is associated with phrenic nerve paralysis for the duration of the block which can exacerbate pulmonary co-morbidities, as well as motor block of the arm which can decrease patient autonomy. An alternative to the interscalene block is the combined suprascapular nerve and axillary nerve (SSAX) block (2). However, this requires two needle punctures and is more difficult to perform technically. Recently, the Infraspinatus Teres Minor Interfascial Plane (ITM) block was developed by Kim et al (1) to anaesthetise the suprascapular and axillary nerves with a single approach. As a fascial plane block, its high safety profile and ease of performance make it a potentially safer alternative the SSAX block when the ISB is contraindicated.

A monocentric, prospective Simon two-stage trial

02

Conditions studied

  • Pain After Shoulder Surgery

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Keywords

  • Postoperative pain
  • Fascial plane block
  • Infraspinatus-teres minor block
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The study population inclusion criteria will be:

    • Patients of any sex
    • Class ASAI-III
    • Patients 18 years of age or older
    • Scheduled for elective shoulder arthroscopy
    • Able to give written informed consent autonomously
    • Sex and gender dimensions are irrelevant for this study as enrolled patients are benefitting from shoulder surgery without reference to gender and our standard care as well as our research disposition is indiscriminately applied to all genders.

Exclusion criteria

Exclusion Criteria:

  • The subject exclusion criteria will be:

    • 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
    • Existing preoperative chronic opioid use (greater than or equal to 3 months of use)
    • Renal insufficiency (GFR\<30ml/min according to the Cockroft-Gault formula)
    • Known or suspected non-compliance
    • Illicit drug use
    • Excessive alcohol use (\<8 drinks per week for women, >15 drinks per week for men)
    • Inability to follow the procedures of the study, e.g due to language problems, psychiatric disorder, dementia, etc
    • Participation in another study with an investigational medicinal product within 30 days preceding the study and during the study
    • Hepatic insufficiency (CHILD-Pugh score B or C)
    • Enrolment of the investigator, his/her family members, employees and other dependent persons
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (estimated)

Study arms

  • Experimental
    Intervention

    Single arm interventional group in a Simon's two stage design

    Other: Infraspinatus-teres minor block

Interventions

  • OtherInfraspinatus-teres minor block

    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.

05

What researchers measure

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.

06

Study locations

1 site
  • Centre Hospitalier Universitaire Vaudois-CHUV
    Lausanne, Canton of Vaud 1011, Switzerland
07

References and documents

Publications

  • Kim SH, Yeo IS, Jang J, Jung HE, Chun YM, Yang HM. Infraspinatus-teres minor (ITM) interfascial block: a novel approach for combined suprascapular and axillary nerve block. Reg Anesth Pain Med. 2024 Jan 11;49(1):67-72. doi: 10.1136/rapm-2023-104738. PubMed 37491150 ↗

Individual participant data

Plan to share: No — Small study with 29 patients and only nine if stopped at stage 1.

08

Registry details

Key details

Study ID
NCT07808008
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Responsible party
Eric Albrecht (Professor Dr. Med Eric Albrecht, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted
Sep 8, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Jun 15, 2027 (estimated)
Completion
Sep 15, 2027 (estimated)
Last update
Sep 11, 2026

Study contacts

Professor Dr. Med Eric Albrecht, DM, MD
Contact
eric.albrecht@chuv.ch
+41 795 566 341
Corey A Kull, MD
Contact
Corey.Kull@chuv.ch
+41 795 566 341

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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