Postoperative PainNCT07670780
Interscalene Block Versus Infraspinatus-Teres Minor Interfascial Plane Block for Shoulder Arthroscopy
A study testing Ultrasound-Guided Interscalene Block and Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane Block in people with Postoperative Pain and Shoulder Arthroscopic Surgeries, run by TC Erciyes University.
Trial summary
This prospective randomized controlled study aims to compare the effects of interscalene block, infraspinatus-teres minor interfascial plane block, and a control group on postoperative analgesia and diaphragmatic function in patients undergoing shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Shoulder Arthroscopic Surgeries, Diaphragmatic Dysfunction
- What is being tested?
- Ultrasound-Guided Interscalene Block and Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 28 Aug 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective shoulder arthroscopy
- No known allergy to study medications
- No psychiatric disorder
- No opioid dependence
Show all 9Show fewer
- Ability to use patient-controlled analgesia (PCA) and complete VAS assessments
- No contraindication to peripheral nerve blocks
- Written informed consent obtained
Who cannot join
- Refusal to participate
- Uncontrolled hypertension
- Chronic pain or ongoing analgesic treatment
- Significant cardiac disease (coronary artery disease, arrhythmia, heart failure)
- Diabetes mellitus
About this study
Official title: Comparison of the Effects of Interscalene Block and Infraspinatus-Teres Minor Interfascial Plane Block on Postoperative Analgesia and Diaphragmatic Function in Patients Undergoing Shoulder Arthroscopy.
This prospective randomized controlled study aims to compare the effects of interscalene block, infraspinatus-teres minor interfascial plane block, and a control group on postoperative analgesia and diaphragmatic function in patients undergoing shoulder arthroscopy. A total of 120 patients will be enrolled and allocated into three groups. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and diaphragmatic function will be evaluated and compared among the groups. The study seeks to determine whether the infraspinatus-teres minor interfascial plane block can provide effective postoperative analgesia with less impact on diaphragmatic function compared with interscalene block.
Read the detailed description
Shoulder arthroscopy is associated with significant postoperative pain. Interscalene block is widely used for analgesia but may impair diaphragmatic function because of phrenic nerve involvement. The infraspinatus-teres minor interfascial plane block has been proposed as an alternative regional anesthesia technique that may provide adequate analgesia while preserving diaphragmatic function. This randomized controlled trial will include 120 adult patients undergoing elective shoulder arthroscopy. Participants will be randomized into three groups: interscalene block, infraspinatus-teres minor interfascial plane block, and control. Pain scores, opioid consumption, time to first rescue analgesia, diaphragmatic excursion measured by ultrasound, and block-related complications will be recorded and analyzed.
- Being tested
- Ultrasound-Guided Interscalene Block, Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane Block
- Keywords
- ınterscalene block, Shoulder Arthroscopy, Regional Anesthesia, Postoperative Analgesia, Diaphragmatic Function, Ultrasound-Guided Block, Infraspinatus-Teres Minor Interfascial Plane Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Interscalene BlockProcedure or surgery
Ultrasound-guided interscalene brachial plexus block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy. The block is administered using ultrasound guidance according to institutional practice.
Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane BlockProcedure or surgery
Ultrasound-guided infraspinatus-teres minor interfascial plane block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy. The block is administered using ultrasound guidance according to institutional practice.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene Block Group | Experimental | Patients receive ultrasound-guided interscalene brachial plexus block for postoperative analgesia following shoulder surgery. Receives: Procedure: Ultrasound-Guided Interscalene Block |
| Infraspinatus-Teres Minor Interfascial Plane Block Group | Experimental | Patients receive ultrasound-guided infraspinatus-teres minor interfascial plane block for postoperative analgesia after shoulder surgery. Receives: Procedure: Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane Block |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) , ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity. compared between study groups.
Measured: 0, 2,4, 6, 12, and 24 hours after surgery
Diaphragmatic Excursion
Comparison of postoperative diaphragmatic excursion measured by ultrasonography between study groups.
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 posted26 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion22 Jun 2028 (estimated)
- Study completion28 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into three parallel groups: interscalene block, infraspinatus-teres minor interfascial plane block, and control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Recep Aksu, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670780
- Sponsor's protocol ID
- 26-AKD-187
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Interscalene Block and Infraspinatus-Teres Minor Interfascial Plane Block on Postoperative Analgesia and Diaphragmatic Function in Patients Undergoing Shoulder Arthroscopy.
- ClinicalTrials.gov ID
- NCT07670780
- Acronym / sponsor ID
- 26-AKD-187
- Keywords
- ınterscalene block, Shoulder Arthroscopy, Regional Anesthesia, Postoperative Analgesia, Diaphragmatic Function, Ultrasound-Guided Block, Infraspinatus-Teres Minor Interfascial Plane Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 22 Jun 2028 (estimated)
- Study completion
- 28 Aug 2028 (estimated)
- First posted
- 26 Jun 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.
This prospective randomized controlled study aims to compare the effects of interscalene block, infraspinatus-teres minor interfascial plane block, and a control group on postoperative analgesia and diaphragmatic function in patients undergoing shoulder arthroscopy. A total of 120 patients will be enrolled and allocated into three groups. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and diaphragmatic function will be evaluated and compared among the groups. The study seeks to determine whether the infraspinatus-teres minor interfascial plane block can provide effective postoperative analgesia with less impact on diaphragmatic function compared with interscalene block.
Detailed description
Shoulder arthroscopy is associated with significant postoperative pain. Interscalene block is widely used for analgesia but may impair diaphragmatic function because of phrenic nerve involvement. The infraspinatus-teres minor interfascial plane block has been proposed as an alternative regional anesthesia technique that may provide adequate analgesia while preserving diaphragmatic function. This randomized controlled trial will include 120 adult patients undergoing elective shoulder arthroscopy. Participants will be randomized into three groups: interscalene block, infraspinatus-teres minor interfascial plane block, and control. Pain scores, opioid consumption, time to first rescue analgesia, diaphragmatic excursion measured by ultrasound, and block-related complications will be recorded and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized into three parallel groups: interscalene block, infraspinatus-teres minor interfascial plane block, and control group.
| Arm | Type | Receives |
|---|---|---|
| Interscalene Block Group | Experimental | Procedure: Ultrasound-Guided Interscalene BlockPatients receive ultrasound-guided interscalene brachial plexus block for postoperative analgesia following shoulder surgery. |
| Infraspinatus-Teres Minor Interfascial Plane Block Group | Experimental | Procedure: Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane BlockPatients receive ultrasound-guided infraspinatus-teres minor interfascial plane block for postoperative analgesia after shoulder surgery. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 65 years
- ASA physical status I-II
- Scheduled for elective shoulder arthroscopy
- No known allergy to study medications
- No psychiatric disorder
Key exclusion criteria (5 listed)
- Refusal to participate
- Uncontrolled hypertension
- Chronic pain or ongoing analgesic treatment
- Significant cardiac disease (coronary artery disease, arrhythmia, heart failure)
- Diabetes mellitus
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 |
|---|---|---|
| Ultrasound-Guided Interscalene BlockUltrasound-guided interscalene brachial plexus block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy. The block is administered using ultrasound guidance according to institutional practice. | Procedure or surgery | Interscalene Block Group |
| Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane BlockUltrasound-guided infraspinatus-teres minor interfascial plane block is performed before induction of anesthesia for postoperative analgesia in patients undergoing shoulder arthroscopy. The block is administered using ultrasound guidance according to institutional practice. | Procedure or surgery | Infraspinatus-Teres Minor Interfascial Plane Block Group |
Primary outcome
Postoperative Pain Intensity
Time frame: 0, 2,4, 6, 12, and 24 hours after surgery
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) , ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. higher scores indicate greater pain intensity. compared between study groups.
Diaphragmatic Excursion
Time frame: 24 hours after surgery
Comparison of postoperative diaphragmatic excursion measured by ultrasonography between study groups.
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 1 Jul 2026.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Interscalene Block and Ultrasound-Guided Infraspinatus-Teres Minor Interfascial Plane Block in people with Postoperative Pain and Shoulder Arthroscopic Surgeries, run by TC Erciyes University.
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 9 inclusion and 5 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Postoperative Pain Intensity (time frame: 0, 2,4, 6, 12, and 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.