- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07688395
Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Analgesia After Shoulder Arthroscopy
July 2, 2026 updated by: Canberk Çetinel, Taksim Egitim ve Arastirma Hastanesi
Novel Analgesic Approaches in Shoulder Surgery: Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Canberk Çetinel, MD
- Phone Number: +905396996239
- Email: canberkc@gmail.com
Study Locations
-
-
Beyoğlu
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Istanbul, Beyoğlu, Turkey (Türkiye), 34433
- Taksim Educational and Research Hospital
-
Contact:
- Canberk Çetinel, MD
- Phone Number: +905396996239
- Email: canberkc@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Erector Spinae Plane Block Group
Patients receiving ultrasound-guided cervical erector spinae plane block for postoperative analgesia.
|
Before shoulder surgery, Ultrasound-guided C8-T1 ESP block will be performed for postoperative analgesia
In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25.
|
|
Active Comparator: Infraspinatus Teres Minor Interfascial Plane Block Group
Patients receiving ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block for postoperative analgesia.
|
In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25.
Before surgery, Ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block will be performed for postoperative analgesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Postoperative 1., 6., 12. and 24. hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total postoperative analgesic consumption
Time Frame: 24 hours after surgery
|
Total amount of rescue analgesics (NSAIDs, paracetamol, and opioids) administered during the first 24 hours after surgery.
Opioid consumption will be converted to intravenous morphine equivalents for analysis, when applicable.
|
24 hours after surgery
|
|
Incidence of postoperative nausea and vomiting (PONV)
Time Frame: 24 hours after surgery
|
Occurrence of postoperative nausea and/or vomiting requiring treatment during the first 24 hours after surgery.
Also, the need for rescue antiemetic medication will be recorded.
|
24 hours after surgery
|
|
Block-related complications
Time Frame: 24 hours after surgery
|
Incidence of block-related complications, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, pneumothorax, persistent sensory or motor deficits, and other procedure-related adverse events.
|
24 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
June 27, 2026
First Submitted That Met QC Criteria
July 2, 2026
First Posted (Actual)
July 7, 2026
Study Record Updates
Last Update Posted (Actual)
July 7, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2024-KAEK-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
Beginning 6 months following publication and ending 5 years after publication.
IPD Sharing 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.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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