NCT06844630

Brief Summary

Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Interscalene brachial plexus block is one of the most preferred techniques among these. Due to the phrenic nerve paralysis frequently seen in interscalene block, alternative diaphragm-sparing block techniques have emerged over time. One of these is the Infraspinatus teres minor interfascial block. Infraspinatus teres minor interfascial block can block both the suprascapular nerve and the axillary nerve, which are effective in the innervation of the shoulder, with a single-point injection. The main aim of our study was to show that there is no difference between interscalene block and infraspinatus-teres-minor interfascial block in terms of their effects on postoperative analgesia in patients undergoing arthroscopic shoulder surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 13, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

February 13, 2025

Last Update Submit

December 22, 2025

Conditions

Keywords

arthroscopic shoulder surgerypostoperative paininterscalene brachial plexus blockinfraspinatus-teres minor interfascial block

Outcome Measures

Primary Outcomes (1)

  • 24 hours opioid consumption

    morphine consumptions via patient controlled analgesia device for both group will be recorded

    Time Frame: up to 24 hours

Secondary Outcomes (3)

  • Sensory and Motor block score

    30 minutes post injection

  • Numeric rating scale for postoperative pain intensity

    up to 24 hours (Will be evaluated at 1, 3, 6, 12, 18, 24 hours)

  • Quality of Recovery - 15 score

    Postoperative 24th hour

Study Arms (2)

Interscalene Block

EXPERIMENTAL

Patients randomized to receive interscalene block

Other: Preoperative block application (İntersclane Block)

Infraspinatus-teres minor (ITM) interfascial block

EXPERIMENTAL

Patients randomized to receive Infraspinatus-teres minor (ITM) interfascial block

Other: Preoperative block application (Infraspinatus-teres minor interfascial block)

Interventions

Before surgery, patients will receive a unilateral interscalene block under ultrasound guidance.

Interscalene Block

Before surgery, patients will receive a unilateral infraspinatus-teres minor interfascial block under ultrasound guidance.

Infraspinatus-teres minor (ITM) interfascial block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification I-II-III
  • Scheduled for arthroscopic shoulder surgery under general anesthesia

You may not qualify if:

  • history of bleeding diathesis
  • receiving anticoagulant treatment
  • infection of the skin at the site of the needle puncture
  • pregnancy or lactation
  • patients who do not accept the procedure
  • Allergy to local anesthetics
  • Chronic pain syndromes requiring opioid intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (3)

  • 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
  • Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print.

    PMID: 30635497BACKGROUND
  • Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.

    PMID: 19282714BACKGROUND

MeSH Terms

Conditions

Shoulder PainPain, Postoperative

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 25, 2025

Study Start

March 1, 2025

Primary Completion

June 30, 2025

Study Completion

August 30, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations