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Injection Site in Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy

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?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07695025
Acronym
ISB-ROOT
Enrollment
50
Registered
2026-07-10
Start date
2026-07-15
Completion date
2026-11-30
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Shoulder Arthroscopy

Keywords

Ultrasound-Guided Interscalene Block, Interscalene Block, Regional Anesthesia, Shoulder Arthroscopy, Postoperative Analgesia, Local Anesthetic, Brachial Plexus Block, Phrenic Nerve

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.

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.

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.

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Analgesic Efficacy12 hours after surgeryPostoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.

Secondary

MeasureTime frameDescription
Time to First Rescue Analgesic12 hours after surgeryTime from the end of surgery to first rescue analgesic administration.
Hemidiaphragmatic ParalysisBefore block and 2 hours after surgeryPresence of ipsilateral hemidiaphragmatic paralysis assessed by ultrasonography.
Block-Related ComplicationsDuring block placement and within 12 hours after surgeryIncidence of vascular puncture, intraneural injection, Horner syndrome, dyspnea, hoarseness, nausea, vomiting, recurrent laryngeal nerve block, stellate ganglion block, and prolonged motor block.
Block Duration12 hours after surgeryDuration of sensory and motor block recorded during postoperative follow-up.

Countries

Turkey (Türkiye)

Contacts

CONTACTHakan Emirkadı, MD
hemirkadi@gmail.com+905322609367
PRINCIPAL_INVESTIGATORTuna Erturk, MD

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026