NCT07695025

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

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress13%
Jul 2026Nov 2026

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2026

Expected
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 5, 2026

Last Update Submit

July 5, 2026

Conditions

Keywords

Ultrasound-Guided Interscalene BlockInterscalene BlockRegional AnesthesiaShoulder ArthroscopyPostoperative AnalgesiaLocal AnestheticBrachial Plexus BlockPhrenic Nerve

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

EXPERIMENTAL

Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle.

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.

Procedure: Ultrasound-Guided Interscalene Block

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.

Anterior Interscalene BlockPosterior Interscalene Block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Tuna Erturk, MD

    Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hakan Emirkadı, MD

CONTACT

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
Model Details: 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.
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.

Locations