Pain After Shoulder SurgeryITMNCT07808008
Analgesic Efficacy of the Infraspinatus-Teres Minor (ITM) Interfascial Plane Block After Shoulder Arthroscopy: A Simon's Two-Stage Design
A study testing Infraspinatus-teres minor block in people with Pain After Shoulder Surgery, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain After Shoulder Surgery
- What is being tested?
- Infraspinatus-teres minor block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2026to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois-CHUV
Lausanne, Canton of Vaud, 1011
Prof. Dr. Med Eric Albrecht, MD, DM, eric.albrecht@chuv.ch
About this study
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
- Conditions
- Pain After Shoulder Surgery
- Being tested
- Infraspinatus-teres minor block
- Keywords
- Postoperative pain, Fascial plane block, Infraspinatus-teres minor block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraspinatus-teres minor blockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Single arm interventional group in a Simon's two stage design Receives: Other: Infraspinatus-teres minor block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficacy
The binary primary endpoint is block success, requiring the two following criteria:
- 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.
- 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.
Measured: At 2 hours postoperatively and at 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain After Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Simon's Two-Stage Design
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808008
- Sponsor's protocol ID
- 2026-02501
- Acronym
- ITM
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Small study with 29 patients and only nine if stopped at stage 1.
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of the Infraspinatus-Teres Minor (ITM) Interfascial Plane Block After Shoulder Arthroscopy: A Simon's Two-Stage Design
- ClinicalTrials.gov ID
- NCT07808008
- Acronym / sponsor ID
- ITM / 2026-02501
- Conditions
- Pain After Shoulder Surgery
- Keywords
- Postoperative pain, Fascial plane block, Infraspinatus-teres minor block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Simon's Two-Stage Design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Infraspinatus-teres minor blockSingle arm interventional group in a Simon's two stage design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The study population inclusion criteria will be:
Key exclusion criteria (14 listed)
- The subject exclusion criteria will be:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infraspinatus-teres minor blockA 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. | Other | Intervention |
Primary outcome
Analgesic efficacy
Time frame: At 2 hours postoperatively and at 24 hours postoperatively.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 37491150Kim 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.
- Individual participant dataSharing planned: No. Small study with 29 patients and only nine if stopped at stage 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraspinatus-teres minor block in people with Pain After Shoulder Surgery, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Dr. Med Eric Albrecht, DM, MD (+41 795 566 341, eric.albrecht@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic efficacy (time frame: At 2 hours postoperatively and at 24 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07808008, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.