NCT07670780

Brief Summary

This prospective randomized controlled study aims to compare the effects of interscalene block, infraspinatus-teres minor interfascial plane block, and a control group on postoperative analgesia and diaphragmatic function in patients undergoing shoulder arthroscopy. A total of 120 patients will be enrolled and allocated into three groups. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and diaphragmatic function will be evaluated and compared among the groups. The study seeks to determine whether the infraspinatus-teres minor interfascial plane block can provide effective postoperative analgesia with less impact on diaphragmatic function compared with interscalene block.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
26mo left

Started Jun 2026

Longer than P75 for not_applicable postoperative-pain

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Aug 2028

First Submitted

Initial submission to the registry

June 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2028

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

June 22, 2026

Last Update Submit

June 29, 2026

Conditions

Keywords

ınterscalene blockShoulder ArthroscopyRegional AnesthesiaPostoperative AnalgesiaDiaphragmatic FunctionUltrasound-Guided BlockInfraspinatus-Teres Minor Interfascial Plane Block

Outcome Measures

Primary Outcomes (2)

  • Postoperative Pain Intensity

    Postoperative pain intensity assessed using the Visual Analog Scale (VAS) , ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity. compared between study groups.

    0, 2,4, 6, 12, and 24 hours after surgery

  • Diaphragmatic Excursion

    Comparison of postoperative diaphragmatic excursion measured by ultrasonography between study groups.

    24 hours after surgery

Study Arms (3)

Interscalene Block Group

EXPERIMENTAL

Patients receive ultrasound-guided interscalene brachial plexus block for postoperative analgesia following shoulder surgery.

Procedure: Ultrasound-Guided Interscalene Block

Infraspinatus-Teres Minor Interfascial Plane Block Group

EXPERIMENTAL

Patients receive ultrasound-guided infraspinatus-teres minor interfascial plane block for postoperative analgesia after shoulder surgery.

Procedure: Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane Block

Control Group

NO INTERVENTION

Interventions

Ultrasound-guided interscalene brachial plexus block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy. The block is administered using ultrasound guidance according to institutional practice.

Interscalene Block Group

Ultrasound-guided infraspinatus-teres minor interfascial plane block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy. The block is administered using ultrasound guidance according to institutional practice.

Infraspinatus-Teres Minor Interfascial Plane Block Group

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 65 years
  • ASA physical status I-II
  • Scheduled for elective shoulder arthroscopy
  • No known allergy to study medications
  • No psychiatric disorder
  • No opioid dependence
  • Ability to use patient-controlled analgesia (PCA) and complete VAS assessments
  • No contraindication to peripheral nerve blocks
  • Written informed consent obtained

You may not qualify if:

  • Refusal to participate
  • Uncontrolled hypertension
  • Chronic pain or ongoing analgesic treatment
  • Significant cardiac disease (coronary artery disease, arrhythmia, heart failure)
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors are blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomized into three parallel groups: interscalene block, infraspinatus-teres minor interfascial plane block, and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

June 22, 2028

Study Completion (Estimated)

August 28, 2028

Last Updated

July 1, 2026

Record last verified: 2026-06