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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interscalene Brachial Plexus Block (ISB) | Experimental | Patients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine. |
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| Infraspinatus-Teres Minor Block (ITM) | Experimental | Patients will receive TM block under ultrasound guidance using 25 ml 0.25% bupivacaine between infraspinatus and teres minor muscles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-block and 30 minutes post-block |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Ahıskalıoğlu, Professor | Ataturk University Department of Anesthesiology and Reanimation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University | Erzurum | 25000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19920426 | Background | 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. | |
| 37491150 | Background | 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. |
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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.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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The anesthesiologist performing the blocks is aware of the group allocation; all other staff and outcome assessors are blinded.
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| 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. |
|
| Duration of Analgesia | Time interval from block completion to initiation of IV PCA fentanyl in each patient. | 0-24 hours post-block |
| 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. | Pre-block and 30 minutes post-block |
| 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. | Pre-block and 30 minutes post-block |
| 31490292 | Background | 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. |
| 35301140 | Background | 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. |
| 18443635 | Background | 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. |
| 37308994 | Background | 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. |
| 39912574 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |