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Arthroscopic Shoulder SurgeryITM-ISBNCT07253740

Interscalene Versus Infraspinatus-Teres Minor Blocks for Arthroscopic Shoulder Surgery

A study testing Interscalene Brachial Plexus Block (ISB) and Infraspinatus-Teres Minor Block (ITM) in people with Arthroscopic Shoulder Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and infraspinatus-teres minor (ITM) blocks for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery. The primary outcome is total 24-hour opioid consumption. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Arthroscopic Shoulder Surgery
What is being tested?
Interscalene Brachial Plexus Block (ISB) and Infraspinatus-Teres Minor Block (ITM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2026to 2 May 2026
Phase
Interventional
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The American Society of Anesthesiologists I-III
  • Scheduled for elective unilateral arthroscopic shoulder surgery
  • Provide written informed consent

Who cannot join

  • Refusal to participate
  • Allergy to study drugs
  • Severe cardiac, renal, or hepatic disease
  • Neurological deficit or neuropathy
  • Anticoagulant therapy
  • Pre-existing respiratory dysfunction
  • Chronic shoulder pain or planned open surgery

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ataturk University

    Erzurum, 25000

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Interscalene and Infraspinatus-Teres Minor Blocks on Postoperative Opioid Consumption and Pain Scores in Patients Undergoing Arthroscopic Shoulder Surgery

This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and infraspinatus-teres minor (ITM) blocks for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery. The primary outcome is total 24-hour opioid consumption. Secondary outcomes include pain scores, hemidiaphragmatic paresis incidence and severity, duration of analgesia, and changes in lung function. Participants are randomized into ISB or ITM groups; blocks are performed under ultrasound guidance. Postoperative pain is managed with patient controlled analgesia(PCA).

Read the detailed description

This is a single-center, prospective, randomized clinical trial designed to compare the efficacy of Interscalene Brachial Plexus Block (ISB) and Infraspinatus-Teres Minor (ITM) interfascial block in patients undergoing elective unilateral arthroscopic shoulder surgery. The primary objective is to compare total 24-hour postoperative opioid consumption. Secondary objectives include the and pain scores, incidence and severity of hemidiaphragmatic paresis, duration of analgesia (from block completion to initiation of IV PCA), and postoperative pulmonary function changes.

This study aims to determine whether the ITM block provides comparable perioperative analgesia to the ISB block while potentially reducing hemidiaphragmatic paresis and pulmonary compromise.

Being tested
Interscalene Brachial Plexus Block (ISB), Infraspinatus-Teres Minor Block (ITM)
Keywords
Postoperative Pain, Analgesia, Regional Anesthesia, Interscalene Brachial Plexus Block, Infraspinatus-Teres Minor Block
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interscalene Brachial Plexus Block (ISB)Procedure or surgery

    Also called Interscalene Nerve Block

    Patients receive ultrasound-guided ISB before arthroscopic shoulder surgery. After sedation with IV midazolam, 15 ml of 0.25% bupivacaine is injected using a 22 Gauge 50 mm needle with posterior in-plane approach, targeting C5-C6 roots.

  • Infraspinatus-Teres Minor Block (ITM)Procedure or surgery

    Patients receive ultrasound-guided ITM interfascial block in sitting position before surgery. Using a 22 Gauge 10 mm needle, 25 ml of 0.25% bupivacaine is injected between infraspinatus and teres minor muscles via out-of-plane or in-plane hydrodissection.

Study groups in NCT07253740
Study groupRoleWhat they receive
Interscalene Brachial Plexus Block (ISB)ExperimentalPatients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine.
Receives: Procedure: Interscalene Brachial Plexus Block (ISB)
Infraspinatus-Teres Minor Block (ITM)ExperimentalPatients will receive TM block under ultrasound guidance using 25 ml 0.25% bupivacaine between infraspinatus and teres minor muscles.
Receives: Procedure: Infraspinatus-Teres Minor Block (ITM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total 24-Hour Postoperative Opioid Consumption

    Total intravenous opioid consumption recorded for each patient during the first 24 hours after arthroscopic shoulder surgery, including any rescue analgesia administered.

    Measured: 0-24 hours postoperatively

Secondary outcomes (4)

  1. Incidence and Severity of Hemidiaphragmatic Paresis

    Ipsilateral hemidiaphragmatic function evaluated by M-mode ultrasonography before block and 30 minutes after block completion. Paresis classified as none (<25% reduction), partial (25-75% reduction), or complete (>75% reduction or paradoxical movement).

    Measured: Pre-block and 30 minutes post-block

  2. Duration of Analgesia

    Time interval from block completion to initiation of IV PCA fentanyl in each patient.

    Measured: 0-24 hours post-block

  3. Pulmonary Function Changes (FEV1)

    Pulmonary function measured with bedside spirometry pre-block and 30 minutes post-block. Forced expiratory volume in 1 second (FEV1) recorded; each measurement performed three times and mean value used.

    Measured: Pre-block and 30 minutes post-block

  4. Pulmonary Function Changes (FVC)

    Pulmonary function measured with bedside spirometry pre-block and 30 minutes post-block. Forced vital capacity (FVC) recorded; each measurement performed three times and mean value used.

    Measured: Pre-block and 30 minutes post-block

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start1 Jan 2026
  3. Primary completion1 May 2026
  4. Study completion2 May 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07253740
Sponsor's protocol ID
ATAUNISHOULDER
Acronym
ITM-ISB
Status last verified
May 2026
First submitted
19 Nov 2025
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional regulations. Data will be securely stored and used solely for the purposes of this study and related scientific publications.

Publications

  • Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.

    PubMed 19920426

  • 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

  • Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.

    PubMed 31490292

  • Teske LG, Pill SG, Lutz A, Thigpen CA, Shanley E, Adams KJ, Bohon H, Graham GD, Marston G, Walker KB, Kissenberth MJ. Single shot interscalene regional anesthesia provides noninferior analgesia and decreased complications compared with an indwelling catheter for arthroscopic and reconstructive shoulder surgery. J Shoulder Elbow Surg. 2022 Jun;31(6S):S152-S157. doi: 10.1016/j.jse.2022.02.004. Epub 2022 Mar 15.

    PubMed 35301140

  • Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.

    PubMed 18443635

  • Luan H, Hao C, Li H, Zhang X, Zhao Z, Zhu P. Effect of interscalene brachial plexus block with dexmedetomidine and ropivacaine on postoperative analgesia in patients undergoing arthroscopic shoulder surgery: a randomized controlled clinical trial. Trials. 2023 Jun 12;24(1):392. doi: 10.1186/s13063-023-07292-2.

    PubMed 37308994

  • Ahiskalioglu A, Karapinar YE, Dagci Y, Yayik AM, Ciftci B, Tulgar S. An alternative sonographic approach to infraspinatus-teres minor interfascial plane block: make it easy. Minerva Anestesiol. 2025 Apr;91(4):359-361. doi: 10.23736/S0375-9393.24.18697-X. Epub 2025 Feb 6. No abstract available.

    PubMed 39912574

Questions about this trial

What is this clinical trial studying?

A study testing Interscalene Brachial Plexus Block (ISB) and Infraspinatus-Teres Minor Block (ITM) in people with Arthroscopic Shoulder Surgery, run by Ataturk University at 1 site in Turkey (Türkiye).

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 3 inclusion and 7 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: finished, as of the sponsor's last update on 14 May 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total 24-Hour Postoperative Opioid Consumption (time frame: 0-24 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 NCT07253740, which also lists 7 linked publications.

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 14 May 2026.

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