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NCT Number: NCT07253740

Interscalene Versus Infraspinatus-Teres Minor Blocks for 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).

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Key information

Conditions

Arthroscopic Shoulder Surgery Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Interscalene Brachial Plexus Block (ISB)

Procedure

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.

Other names: Interscalene Nerve Block

Infraspinatus-Teres Minor Block (ITM)

Procedure

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.

Primary outcomes

  1. Total 24-Hour Postoperative Opioid Consumption

    Time frame: 0-24 hours postoperatively

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

Secondary outcomes

  1. Incidence and Severity of Hemidiaphragmatic Paresis

    Time frame: Pre-block and 30 minutes post-block

    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).

  2. Duration of Analgesia

    Time frame: 0-24 hours post-block

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

  3. Pulmonary Function Changes (FEV1)

    Time frame: Pre-block and 30 minutes post-block

    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.

  4. Pulmonary Function Changes (FVC)

    Time frame: Pre-block and 30 minutes post-block

    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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: ITM-ISB

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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