NCT07688395

Brief Summary

The shoulder, being an anatomical region innervated by different nerves, has a wide variety of analgesic approaches, which differ depending on the practitioner. New approaches are being developed based on the different innervation channels demonstrated in clinical and cadaver studies. Over time, the effectiveness of axillary block, suprascapular block, interscalene block, local infiltration, and various combinations, as well as non-regional methods, has been observed. The goal of these approaches is to achieve the highest possible level of patient comfort, high analgesic efficacy, and minimal complications. Studies have shown that the interscalene block has the highest analgesic efficacy and the most ideal postoperative results; therefore, it is frequently used as the gold standard in this field. Providing effective analgesia with a single intervention can also be cited as an aspect that increases patient comfort and simplifies the procedure. In interscalene block; unilateral transient diaphragmatic paralysis due to the spread of local anesthetics to the C7 nerve root, respiratory problems and potential spinal/epidural complications, new approaches are being followed and researched. Results from cervical/high thoracic erector spinae plane block (ESPB) and infraspinatus-teres minor interfascial plane block (ITMIPB) studies, which are the subject of new studies, strengthen the hypothesis that they provide effective analgesia. Neither of these blocks, performed with ultrasonography, carries the risks present in interscalene block. Although the usual risks of a peripheral nerve block are present for these procedures; the block sites are considered safer due to its distance from vascular structures and the reduced risk of additional complications. While small sample studies exist for each type of block, no studies comparing their effectiveness have been found. Besides reduced complications, another advantage of these two blocks is their ability to provide effective analgesia with a single-point injection. The aim of this study is to compare the analgesic efficacy of Cervical Erector Spine Plane Block (ESP) and Infraspinatus-Teres Minor Interfascial Plane Block (ITMIPB) applied for postoperative analgesia in ASA I-III patients undergoing shoulder surgery.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet 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

Study Progress9%
Jul 2026Jul 2027

First Submitted

Initial submission to the registry

June 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

June 27, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

postoperative analgesiaregional anesthesiashoulder arthroscopyultrasonography

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain intensity

    Pain intensity assessed using the 11-point Numeric Rating Scale (NRS; 0=no pain, 10=worst imaginable pain).

    Postoperative 1., 6., 12. and 24. hour

Secondary Outcomes (3)

  • Total postoperative analgesic consumption

    24 hours after surgery

  • Incidence of postoperative nausea and vomiting (PONV)

    24 hours after surgery

  • Block-related complications

    24 hours after surgery

Study Arms (2)

Erector Spinae Plane Block Group

ACTIVE COMPARATOR

Patients receiving ultrasound-guided cervical erector spinae plane block for postoperative analgesia.

Procedure: cervical erector spinae plane blockDrug: Bupivacaine %0.25 (isobaric)

Infraspinatus Teres Minor Interfascial Plane Block Group

ACTIVE COMPARATOR

Patients receiving ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block for postoperative analgesia.

Procedure: Infraspinatus Teres Minor Interfascial Plane BlockDrug: Bupivacaine %0.25 (isobaric)

Interventions

Before shoulder surgery, Ultrasound-guided C8-T1 ESP block will be performed for postoperative analgesia

Erector Spinae Plane Block Group

Before surgery, Ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block will be performed for postoperative analgesia

Infraspinatus Teres Minor Interfascial Plane Block Group

In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25.

Erector Spinae Plane Block GroupInfraspinatus Teres Minor Interfascial Plane Block Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults scheduled for elective shoulder arthroscopy
  • ASA I-II-III patients
  • Patients age between 18-80

You may not qualify if:

  • Patients with previously known allergy to local anesthetics.
  • Patients with insufficient pulmonary functions (Severe obstruction or restriction in Pulmonary Function Test)
  • Patients with ASA IV or higher
  • Patients who suffered from any complications related to anesthesia or surgery
  • Patients with additional body part injury
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taksim Educational and Research Hospital

Istanbul, Beyoğlu, 34433, Turkey (Türkiye)

Location

Related Publications (5)

  • Eckmann MS, Bickelhaupt B, Fehl J, Benfield JA, Curley J, Rahimi O, Nagpal AS. Cadaveric Study of the Articular Branches of the Shoulder Joint. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):564-570. doi: 10.1097/AAP.0000000000000652.

    PMID: 28786899BACKGROUND
  • Ma D, Wang R, Wen H, Li H, Jiang J. Cervical erector spinae plane block as a perioperative analgesia method for shoulder arthroscopy: a case series. J Anesth. 2021 Jun;35(3):446-450. doi: 10.1007/s00540-021-02907-x. Epub 2021 Mar 8.

    PMID: 33686465BACKGROUND
  • 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
  • Desai N. Postoperative analgesia for shoulder surgery. Br J Hosp Med (Lond). 2017 Sep 2;78(9):511-515. doi: 10.12968/hmed.2017.78.9.511.

    PMID: 28898151BACKGROUND
  • Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.

    PMID: 35550031BACKGROUND

Central Study Contacts

Canberk Çetinel, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Our study is a single-blind study. Outcome Assessor will be masked to performed block type.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2026

First Posted

July 7, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Beginning 6 months following publication and ending 5 years after publication.
Access Criteria
Individual participant data will be available to qualified researchers upon reasonable request to the principal investigator. Requests will be evaluated based on scientific merit and ethical considerations.

Locations