Shoulder ArthroscopyISB-ROOTNCT07695025
Injection Site in Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy
A study testing Ultrasound-Guided Interscalene Block in people with Shoulder Arthroscopy and Postoperative Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound-guided interscalene block is commonly used for postoperative analgesia in patients undergoing shoulder arthroscopy. The location of local anesthetic injection may influence both block efficacy and the incidence of block-related complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroscopy, Postoperative Pain
- What is being tested?
- Ultrasound-Guided Interscalene Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 30 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older. ASA physical status I-III. Scheduled for shoulder arthroscopy under general anesthesia with a planned ultrasound-guided interscalene block for postoperative analgesia.
- Able to provide written informed consent. Normal coagulation parameters and no antithrombotic therapy. No infection or anatomical abnormality at the injection site. No known allergy to local anesthetics. No contralateral diaphragmatic paralysis or pneumothorax. No dyspnea and adequate pulmonary function.
Who cannot join
- Age younger than 18 years or ASA physical status IV. Antithrombotic therapy or abnormal coagulation parameters. Infection or anatomical abnormality at the injection site. Known allergy to local anesthetics. Contralateral diaphragmatic paralysis or history of pneumothorax. Dyspnea. Refusal to undergo interscalene block.
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
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Istanbul, 34668
Hakan drhemirkadi, 05322609367, hemirkadi@gmail.com
About this study
Official title: Does the Injection Site of Local Anesthetic Around the C5-C7 Nerve Roots Affect Block Success and Complication Rates During Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy?
Ultrasound-guided interscalene block is commonly used for postoperative analgesia in patients undergoing shoulder arthroscopy. The location of local anesthetic injection may influence both block efficacy and the incidence of block-related complications. This randomized, double-blind clinical trial compares two different injection sites around the C5-C7 nerve roots using the same local anesthetic dose and volume. The study will assess block success, postoperative analgesia, opioid consumption, diaphragmatic function, and procedure-related complications.
Read the detailed description
Patients scheduled for elective shoulder arthroscopy under general anesthesia will be randomly assigned to one of two ultrasound-guided interscalene block techniques. In one group, the local anesthetic will be injected between the C5-C7 nerve roots and the anterior scalene muscle. In the other group, the injection will be performed between the C5-C7 nerve roots and the middle scalene muscle. The same local anesthetic solution, volume, and concentration will be used in both groups.
Block success, postoperative pain control, opioid consumption, diaphragmatic movement assessed by ultrasonography, and block-related complications including vascular puncture, Horner syndrome, hoarseness, dyspnea, nausea, vomiting, and prolonged motor block will be recorded and compared between the groups.
- Conditions
- Shoulder Arthroscopy, Postoperative Pain
- Being tested
- Ultrasound-Guided Interscalene Block
- Keywords
- Ultrasound-Guided Interscalene Block, Interscalene Block, Regional Anesthesia, Shoulder Arthroscopy, Postoperative Analgesia, Local Anesthetic, Brachial Plexus Block, Phrenic Nerve
- 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 performed before induction of general anesthesia. Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Anterior Interscalene Block | Experimental | Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle. Receives: Procedure: Ultrasound-Guided Interscalene Block |
| Posterior Interscalene Block | Experimental | Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the middle scalene muscle. Receives: Procedure: Ultrasound-Guided Interscalene Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Analgesic Efficacy
Postoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.
Measured: 12 hours after surgery
Secondary outcomes (4)
Time to First Rescue Analgesic
Time from the end of surgery to first rescue analgesic administration.
Measured: 12 hours after surgery
Hemidiaphragmatic Paralysis
Presence of ipsilateral hemidiaphragmatic paralysis assessed by ultrasonography.
Measured: Before block and 2 hours after surgery
Block-Related Complications
Incidence of vascular puncture, intraneural injection, Horner syndrome, dyspnea, hoarseness, nausea, vomiting, recurrent laryngeal nerve block, stellate ganglion block, and prolonged motor block.
Measured: During block placement and within 12 hours after surgery
Block Duration
Duration of sensory and motor block recorded during postoperative follow-up.
Measured: 12 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 posted10 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel groups receiving ultrasound-guided interscalene block with local anesthetic injected either anterior or posterior to the C5-C7 nerve roots.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Emirkadı, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Investigators
- Tuna Erturk, MD, Principal investigator, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695025
- Sponsor's protocol ID
- 21-19
- Acronym
- ISB-ROOT
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no data sharing plan has been established for this investigator-initiated study.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Injection Site of Local Anesthetic Around the C5-C7 Nerve Roots Affect Block Success and Complication Rates During Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy?
- ClinicalTrials.gov ID
- NCT07695025
- Acronym / sponsor ID
- ISB-ROOT / 21-19
- Conditions
- Shoulder Arthroscopy, Postoperative Pain
- Keywords
- Ultrasound-Guided Interscalene Block, Interscalene Block, Regional Anesthesia, Shoulder Arthroscopy, Postoperative Analgesia, Local Anesthetic, Brachial Plexus Block, Phrenic Nerve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 10 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.
Ultrasound-guided interscalene block is commonly used for postoperative analgesia in patients undergoing shoulder arthroscopy. The location of local anesthetic injection may influence both block efficacy and the incidence of block-related complications. This randomized, double-blind clinical trial compares two different injection sites around the C5-C7 nerve roots using the same local anesthetic dose and volume. The study will assess block success, postoperative analgesia, opioid consumption, diaphragmatic function, and procedure-related complications.
Detailed description
Patients scheduled for elective shoulder arthroscopy under general anesthesia will be randomly assigned to one of two ultrasound-guided interscalene block techniques. In one group, the local anesthetic will be injected between the C5-C7 nerve roots and the anterior scalene muscle. In the other group, the injection will be performed between the C5-C7 nerve roots and the middle scalene muscle. The same local anesthetic solution, volume, and concentration will be used in both groups.
Block success, postoperative pain control, opioid consumption, diaphragmatic movement assessed by ultrasonography, and block-related complications including vascular puncture, Horner syndrome, hoarseness, dyspnea, nausea, vomiting, and prolonged motor block will be recorded and compared between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups receiving ultrasound-guided interscalene block with local anesthetic injected either anterior or posterior to the C5-C7 nerve roots.
| Arm | Type | Receives |
|---|---|---|
| Anterior Interscalene Block | Experimental | Procedure: Ultrasound-Guided Interscalene BlockUltrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle. |
| Posterior Interscalene Block | Experimental | Procedure: Ultrasound-Guided Interscalene BlockUltrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the middle scalene muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older. ASA physical status I-III. Scheduled for shoulder arthroscopy under general anesthesia with a planned ultrasound-guided interscalene block for postoperative analgesia.
- Able to provide written informed consent. Normal coagulation parameters and no antithrombotic therapy. No infection or anatomical abnormality at the injection site. No known allergy to local anesthetics. No contralateral diaphragmatic paralysis or pneumothorax. No dyspnea and adequate pulmonary function.
Key exclusion criteria (1 listed)
- Age younger than 18 years or ASA physical status IV. Antithrombotic therapy or abnormal coagulation parameters. Infection or anatomical abnormality at the injection site. Known allergy to local anesthetics. Contralateral diaphragmatic paralysis or history of pneumothorax. Dyspnea. Refusal to undergo interscalene block.
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 performed before induction of general anesthesia. Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol. | Procedure or surgery | Anterior Interscalene Block, Posterior Interscalene Block |
Primary outcome
Postoperative Analgesic Efficacy
Time frame: 12 hours after surgery
Postoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.
4 secondary outcomes
Time to First Rescue Analgesic
Time frame: 12 hours after surgery
Hemidiaphragmatic Paralysis
Time frame: Before block and 2 hours after surgery
Block-Related Complications
Time frame: During block placement and within 12 hours after surgery
Block Duration
Time frame: 12 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 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no data sharing plan has been established for this investigator-initiated study.
Related trials for Shoulder Arthroscopy
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Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
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ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain
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Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
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RecruitingObservational study
SPSIP Block in Shoulder Artroscopy
Shoulder Arthroscopic Surgeries
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.
Tuna Erturk, MD principal investigator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Interscalene Block in people with Shoulder Arthroscopy and Postoperative Pain, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 1 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 10 Jul 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 Hakan Emirkadı, MD (+905322609367, hemirkadi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Analgesic Efficacy (time frame: 12 hours after surgery). 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 10 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.