Shoulder PainNCT06844630
Interscalene vs Infraspinatus-teres Minor (ITM) Interfascial Block in Shoulder Surgery
A study testing Preoperative block application (İntersclane Block) and Preoperative block application (Infraspinatus-teres minor interfascial block) in people with Shoulder Pain and Pain, Postoperative, run by Kadem Koc at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain, Pain, Postoperative, Surgical Procedure, Unspecified
- What is being tested?
- Preoperative block application (İntersclane Block) and Preoperative block application (Infraspinatus-teres minor interfascial block)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II-III
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Who cannot join
- history of bleeding diathesis
- receiving anticoagulant treatment
- infection of the skin at the site of the needle puncture
- pregnancy or lactation
- patients who do not accept the procedure
- Allergy to local anesthetics
- Chronic pain syndromes requiring opioid intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Analgesic Efficacy Between the Interscalene Block and Infraspinatus-Teres Minor Interfascial Blocks in Patients Undergoing Arthroscopic Shoulder Surgery
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Interscalene brachial plexus block is one of the most preferred techniques among these.
Due to the phrenic nerve paralysis frequently seen in interscalene block, alternative diaphragm-sparing block techniques have emerged over time. One of these is the Infraspinatus teres minor interfascial block. Infraspinatus teres minor interfascial block can block both the suprascapular nerve and the axillary nerve, which are effective in the innervation of the shoulder, with a single-point injection.
The main aim of our study was to show that there is no difference between interscalene block and infraspinatus-teres-minor interfascial block in terms of their effects on postoperative analgesia in patients undergoing arthroscopic shoulder surgery.
- Being tested
- Preoperative block application (İntersclane Block), Preoperative block application (Infraspinatus-teres minor interfascial block)
- Keywords
- arthroscopic shoulder surgery, postoperative pain, interscalene brachial plexus block, infraspinatus-teres minor interfascial block
- Medical subject headings
- Shoulder Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative block application (İntersclane Block)Other
Before surgery, patients will receive a unilateral interscalene block under ultrasound guidance.
Preoperative block application (Infraspinatus-teres minor interfascial block)Other
Before surgery, patients will receive a unilateral infraspinatus-teres minor interfascial block under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene Block | Experimental | Patients randomized to receive interscalene block Receives: Other: Preoperative block application (İntersclane Block) |
| Infraspinatus-teres minor (ITM) interfascial block | Experimental | Patients randomized to receive Infraspinatus-teres minor (ITM) interfascial block Receives: Other: Preoperative block application (Infraspinatus-teres minor interfascial block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours opioid consumption
morphine consumptions via patient controlled analgesia device for both group will be recorded
Measured: Time Frame: up to 24 hours
Secondary outcomes (3)
Sensory and Motor block score
Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite. Block level will be evaluated between 0-8 points score
Measured: 30 minutes post injection
Numeric rating scale for postoperative pain intensity
Evaluated with a Numerical rating scale (NRS) from 0 to 10. (0=no pain; 10=worst imaginable pain)
Measured: up to 24 hours (Will be evaluated at 1, 3, 6, 12, 18, 24 hours)
Quality of Recovery - 15 score
The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool. Each question is scored between 0 and 10. The survey result varies between 0-150 points based on the answers given by the patients. Higher scores indicate better recovery.
Measured: Postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Mar 2025
- Primary completion30 Jun 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kadem Koc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kadem Koc, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844630
- Sponsor's protocol ID
- SamsunOm
- Status last verified
- Dec 2025
- First submitted
- 13 Feb 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SH, Yeo IS, Jang J, Jung HE, Chun YM, Yang HM. Infraspinatus-teres minor (ITM) interfascial block: a novel approach for combined suprascapular and axillary nerve block. Reg Anesth Pain Med. 2024 Jan 11;49(1):67-72. doi: 10.1136/rapm-2023-104738.
PubMed 37491150Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print.
PubMed 30635497Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
PubMed 19282714
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy Between the Interscalene Block and Infraspinatus-Teres Minor Interfascial Blocks in Patients Undergoing Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06844630
- Acronym / sponsor ID
- SamsunOm
- Keywords
- arthroscopic shoulder surgery, postoperative pain, interscalene brachial plexus block, infraspinatus-teres minor interfascial block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kadem KocUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 25 Feb 2025 (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.
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Interscalene brachial plexus block is one of the most preferred techniques among these.
Due to the phrenic nerve paralysis frequently seen in interscalene block, alternative diaphragm-sparing block techniques have emerged over time. One of these is the Infraspinatus teres minor interfascial block. Infraspinatus teres minor interfascial block can block both the suprascapular nerve and the axillary nerve, which are effective in the innervation of the shoulder, with a single-point injection.
The main aim of our study was to show that there is no difference between interscalene block and infraspinatus-teres-minor interfascial block in terms of their effects on postoperative analgesia in patients undergoing arthroscopic shoulder surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene Block | Experimental | Other: Preoperative block application (İntersclane Block)Patients randomized to receive interscalene block |
| Infraspinatus-teres minor (ITM) interfascial block | Experimental | Other: Preoperative block application (Infraspinatus-teres minor interfascial block)Patients randomized to receive Infraspinatus-teres minor (ITM) interfascial block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II-III
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Key exclusion criteria (7 listed)
- history of bleeding diathesis
- receiving anticoagulant treatment
- infection of the skin at the site of the needle puncture
- pregnancy or lactation
- patients who do not accept the procedure
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 |
|---|---|---|
| Preoperative block application (İntersclane Block)Before surgery, patients will receive a unilateral interscalene block under ultrasound guidance. | Other | Interscalene Block |
| Preoperative block application (Infraspinatus-teres minor interfascial block)Before surgery, patients will receive a unilateral infraspinatus-teres minor interfascial block under ultrasound guidance. | Other | Infraspinatus-teres minor (ITM) interfascial block |
Primary outcome
24 hours opioid consumption
Time frame: Time Frame: up to 24 hours
morphine consumptions via patient controlled analgesia device for both group will be recorded
3 secondary outcomes
Sensory and Motor block score
Time frame: 30 minutes post injection
Numeric rating scale for postoperative pain intensity
Time frame: up to 24 hours (Will be evaluated at 1, 3, 6, 12, 18, 24 hours)
Quality of Recovery - 15 score
Time frame: Postoperative 24th hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 37491150Kim SH, Yeo IS, Jang J, Jung HE, Chun YM, Yang HM. Infraspinatus-teres minor (ITM) interfascial block: a novel approach for combined suprascapular and axillary nerve block. Reg Anesth Pain Med. 2024 Jan 11;49(1):67-72. doi: 10.1136/rapm-2023-104738.
- Background: PubMed 30635497Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print.
- Background: PubMed 19282714Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative block application (İntersclane Block) and Preoperative block application (Infraspinatus-teres minor interfascial block) in people with Shoulder Pain and Pain, Postoperative, run by Kadem Koc 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 29 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hours opioid consumption (time frame: Time Frame: up to 24 hours). 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 NCT06844630, which also lists 3 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 29 Dec 2025.