Shoulder Arthroscopic SurgeryNCT07688395
Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Analgesia After Shoulder Arthroscopy
A study testing cervical erector spinae plane block, Infraspinatus Teres Minor Interfascial Plane Block and Bupivacaine %0.25 (isobaric) in people with Shoulder Arthroscopic Surgery, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Arthroscopic Surgery
- What is being tested?
- cervical erector spinae plane block, Infraspinatus Teres Minor Interfascial Plane Block and Bupivacaine %0.25 (isobaric)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults scheduled for elective shoulder arthroscopy
- ASA I-II-III patients
- Patients age between 18-80
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Taksim Educational and Research Hospital
Istanbul, Beyoğlu, 34433
Canberk Çetinel, MD, +905396996239, canberkc@gmail.com
About this study
Official title: 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.
- Conditions
- Shoulder Arthroscopic Surgery
- Being tested
- cervical erector spinae plane block, Infraspinatus Teres Minor Interfascial Plane Block, Bupivacaine %0.25 (isobaric)
- Keywords
- postoperative analgesia, regional anesthesia, shoulder arthroscopy, ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical erector spinae plane blockProcedure or surgery
Before shoulder surgery, Ultrasound-guided C8-T1 ESP block will be performed for postoperative analgesia
Infraspinatus Teres Minor Interfascial Plane BlockProcedure or surgery
Before surgery, Ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block will be performed for postoperative analgesia
Bupivacaine %0.25 (isobaric)Drug
In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block Group | Active comparator | Patients receiving ultrasound-guided cervical erector spinae plane block for postoperative analgesia. Receives: Procedure: cervical erector spinae plane block; Drug: 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. Receives: Procedure: Infraspinatus Teres Minor Interfascial Plane Block; Drug: Bupivacaine %0.25 (isobaric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS; 0=no pain, 10=worst imaginable pain).
Measured: Postoperative 1., 6., 12. and 24. hour
Secondary outcomes (3)
Total postoperative analgesic consumption
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.
Measured: 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
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.
Measured: 24 hours after surgery
Block-related complications
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.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Shoulder Arthroscopic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taksim Egitim ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Canberk Çetinel, Taksim Egitim ve Arastirma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688395
- Sponsor's protocol ID
- 2024-KAEK-12
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28786899Ma 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.
PubMed 33686465Ahiskalioglu 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.
PubMed 39912574Desai 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.
PubMed 28898151Kapukaya 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.
PubMed 35550031
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Analgesic Approaches in Shoulder Surgery: Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block
- ClinicalTrials.gov ID
- NCT07688395
- Acronym / sponsor ID
- 2024-KAEK-12
- Conditions
- Shoulder Arthroscopic Surgery
- Keywords
- postoperative analgesia, regional anesthesia, shoulder arthroscopy, ultrasonography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taksim Egitim ve Arastirma HastanesiOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block Group | Active comparator | Procedure: cervical erector spinae plane block, Drug: Bupivacaine %0.25 (isobaric)Patients receiving ultrasound-guided cervical erector spinae plane block for postoperative analgesia. |
| Infraspinatus Teres Minor Interfascial Plane Block Group | Active comparator | Procedure: Infraspinatus Teres Minor Interfascial Plane Block, Drug: Bupivacaine %0.25 (isobaric)Patients receiving ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block for postoperative analgesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults scheduled for elective shoulder arthroscopy
- ASA I-II-III patients
- Patients age between 18-80
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical erector spinae plane blockBefore shoulder surgery, Ultrasound-guided C8-T1 ESP block will be performed for postoperative analgesia | Procedure or surgery | Erector Spinae Plane Block Group |
| Infraspinatus Teres Minor Interfascial Plane BlockBefore surgery, Ultrasound-guided Infraspinatus Teres Minor Interfascial Plane Block will be performed for postoperative analgesia | Procedure or surgery | Infraspinatus Teres Minor Interfascial Plane Block Group |
| Bupivacaine %0.25 (isobaric)In the both groups, peripheral nerve blocks are performed by using Bupivacaine %0,25. | Drug | Erector Spinae Plane Block Group, Infraspinatus Teres Minor Interfascial Plane Block Group |
Primary outcome
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).
3 secondary outcomes
Total postoperative analgesic consumption
Time frame: 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 24 hours after surgery
Block-related complications
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 28786899Eckmann 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.
- Background: PubMed 33686465Ma 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.
- Background: PubMed 39912574Ahiskalioglu 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.
- Background: PubMed 28898151Desai 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.
- Background: PubMed 35550031Kapukaya 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical erector spinae plane block, Infraspinatus Teres Minor Interfascial Plane Block and Bupivacaine %0.25 (isobaric) in people with Shoulder Arthroscopic Surgery, run by Taksim Egitim ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Canberk Çetinel, MD (+905396996239, canberkc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: Postoperative 1., 6., 12. and 24. hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07688395, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.