NCT07253740

Brief 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. 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2026

Completed
Last Updated

January 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

November 19, 2025

Last Update Submit

January 1, 2026

Conditions

Keywords

Postoperative PainAnalgesiaRegional AnesthesiaInterscalene Brachial Plexus BlockInfraspinatus-Teres Minor Block

Outcome Measures

Primary Outcomes (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.

    0-24 hours postoperatively

Secondary Outcomes (4)

  • Incidence and Severity of Hemidiaphragmatic Paresis

    Pre-block and 30 minutes post-block

  • Duration of Analgesia

    0-24 hours post-block

  • Pulmonary Function Changes (FEV1)

    Pre-block and 30 minutes post-block

  • Pulmonary Function Changes (FVC)

    Pre-block and 30 minutes post-block

Study Arms (2)

Interscalene Brachial Plexus Block (ISB)

EXPERIMENTAL

Patients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine.

Procedure: Interscalene Brachial Plexus Block (ISB)

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.

Procedure: Infraspinatus-Teres Minor Block (ITM)

Interventions

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.

Also known as: Interscalene Nerve Block
Interscalene Brachial Plexus Block (ISB)

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.

Infraspinatus-Teres Minor Block (ITM)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, 25000, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • 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.

    PMID: 19920426BACKGROUND
  • 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: 37491150BACKGROUND
  • 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.

    PMID: 31490292BACKGROUND
  • 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.

    PMID: 35301140BACKGROUND
  • 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.

    PMID: 18443635BACKGROUND
  • 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.

    PMID: 37308994BACKGROUND
  • 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.

    PMID: 39912574BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Ali Ahıskalıoğlu, Professor

    Ataturk University Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ahıskalıoğlu, Professor

CONTACT

Ramazan Altunkaynak, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The anesthesiologist performing the blocks is aware of the group allocation; all other staff and outcome assessors are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Ali Ahıskalıoğlu

Study Record Dates

First Submitted

November 19, 2025

First Posted

November 28, 2025

Study Start

January 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 2, 2026

Last Updated

January 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations