Injection Site in Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy
ISB-ROOT
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?
1 other identifier
interventional
50
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2026
CompletedFirst Posted
Study publicly available on registry
July 10, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
July 10, 2026
July 1, 2026
4 months
July 5, 2026
July 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Analgesic Efficacy
Postoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.
12 hours after surgery
Secondary Outcomes (4)
Time to First Rescue Analgesic
12 hours after surgery
Hemidiaphragmatic Paralysis
Before block and 2 hours after surgery
Block-Related Complications
During block placement and within 12 hours after surgery
Block Duration
12 hours after surgery
Study Arms (2)
Anterior Interscalene Block
EXPERIMENTALUltrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle.
Posterior Interscalene Block
EXPERIMENTALUltrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the middle scalene muscle.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Istanbul, 34668, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuna Erturk, MD
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants were unaware of group assignment. Postoperative assessments were performed by an anesthesiologist who was not involved in block placement and was blinded to treatment allocation. The anesthesiologist performing the block was aware of group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigato
Study Record Dates
First Submitted
July 5, 2026
First Posted
July 10, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
November 10, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
July 10, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared because no data sharing plan has been established for this investigator-initiated study.