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Clinical Trials/NCT07688395
NCT07688395Not yet recruitingNot Applicable

Novel Analgesic Approaches in Shoulder Surgery: Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block

Taksim Egitim ve Arastirma Hastanesi1 site in 1 country100 target enrollmentStarted: October 1, 2026Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Postoperative pain intensity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Masking Description

Our study is a single-blind study. Outcome Assessor will be masked to performed block type.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

Infraspinatus Teres Minor Interfascial Plane Block Group

Active Comparator

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

Intervention: Bupivacaine %0.25 (isobaric) (Drug)

Erector Spinae Plane Block Group

Active Comparator

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

Intervention: cervical erector spinae plane block (Procedure)

Infraspinatus Teres Minor Interfascial Plane Block Group

Active Comparator

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

Intervention: Infraspinatus Teres Minor Interfascial Plane Block (Procedure)

Erector Spinae Plane Block Group

Active Comparator

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

Intervention: Bupivacaine %0.25 (isobaric) (Drug)

Outcomes

Primary Outcomes

Postoperative pain intensity

Time Frame: Postoperative 1., 6., 12. and 24. hour

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Taksim Egitim ve Arastirma Hastanesi
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Canberk Çetinel

Principal Investigator

Taksim Egitim ve Arastirma Hastanesi

Study Sites (1)

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