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

NCT07808008 | Not Yet Recruiting

• 1 other identifier: 2026-02501
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain After Shoulder Surgery

Keywords

Postoperative pain; Fascial plane block; Infraspinatus-teres minor block

Outcome Measures

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.

  At 2 hours postoperatively and at 24 hours postoperatively.

Study Arms (1)

Intervention

EXPERIMENTAL

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

Other: Infraspinatus-teres minor block

Interventions

Infraspinatus-teres minor block OTHER

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.

Intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois-CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37491150 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Professor Dr. Med Eric Albrecht, DM, MD

CONTACT

+41 795 566 341; eric.albrecht@chuv.ch

Corey A Kull, MD

CONTACT

+41 795 566 341; Corey.Kull@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Med Eric Albrecht

Model Details: A Simon's Two-Stage Design

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 8, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)