NCT07739303

Brief Summary

Shoulder surgeries are among the most frequently performed orthopedic interventions and are often associated with moderate to severe postoperative pain. In these procedures, effective pain management is crucial for early rehabilitation and patient comfort. Peripheral nerve blockade is widely used for postoperative analgesia in shoulder surgery. While the interscalene brachial plexus block is considered the gold standard for pain control, it is frequently associated with unintended phrenic nerve blockade, leading to hemidiaphragmatic paresis. To minimize respiratory complications while maintaining effective analgesia, alternative diaphragm-sparing regional anesthesia techniques, such as the combination of suprascapular and axillary nerve blocks, have been introduced. The aim of this study is to compare the analgesic efficacy and respiratory functions preservation of the ultrasound-guided anterior approach suprascapular combined with axillary nerve block versus interscalene block in patients undergoing shoulder surgery

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Aug 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

First Submitted

Initial submission to the registry

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

August 14, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2026

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2026

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Shoulder ArthroscopyInterscalene BlockAnterior Suprascapular BlockAxillary BlockPain Management

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity at Rest

    Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 4 hours after surgery.

    4 hours after surgery.

Secondary Outcomes (8)

  • Postoperative Pain Intensity at Rest

    Up to 24 hours

  • Postoperative Pain Intensity at Movement

    Up to 24 hours

  • Total Postoperative Opioid Consumption

    Up to 24 hours

  • Area Under Curve

    At the 24th hour

  • Diaphragmatic Excursion

    Baseline (immediately before block performance) and 30 minutes after block performance

  • +3 more secondary outcomes

Study Arms (2)

Interscalene Block

ACTIVE COMPARATOR

After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely at the level of the cricoid cartilage (C6) with the head turned to the contralateral side. Advancing the needle laterally into the interscalene groove between the anterior and middle scalene muscles, 10 mL of local anesthetic (%0.5 bupivacaine ) will be injected between the C5 and C6 nerve roots.

Procedure: Interscalene Block

Combination of Axillary and Anterior Suprascapular Blocks

ACTIVE COMPARATOR

After the patients are placed under monitoring and positioned supine, and appropriate field sterilization is achieved, the ultrasound probe will be positioned transversely in the supraclavicular fossa with the head turned to the contralateral side. Advancing the needle in-plane, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the suprascapular nerve as it branches anteriorly from the superior trunk of the brachial plexus. Subsequently, for the axillary nerve block, the patient will be positioned laterally and the ultrasound probe will be placed longitudinally over the posterior aspect of the shoulder. Advancing the needle into the quadrangular space, 5 mL of local anesthetic (%0.5 bupivacaine) will be injected around the axillary nerve adjacent to the posterior circumflex humeral artery.

Procedure: Combination of Axillary and Anterior Suprascapular Blocks

Interventions

Interscalene block will be performed on the patients using 10 mL of 0.5% bupivacaine under ultrasound guidance.

Interscalene Block

Combined anterior suprascapular(5 ml) and axillary nerve blocks(5 ml) will be performed on the patients using a total of 10 mL of 0.5% bupivacaine under ultrasound guidance.

Combination of Axillary and Anterior Suprascapular Blocks

Eligibility Criteria

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

You may qualify if:

  • Patients aged between 18 and 65 years
  • American Society of Anesthesiologists (ASA) physical status I, II, or III
  • Patients scheduled to undergo elective arthroscopic shoulder surgery
  • BMI between 18 and 30 kg/m2
  • Ability to provide written informed consent

You may not qualify if:

  • Known allergy or hypersensitivity to local anesthetics
  • Presence of localized infection at the planned injection site
  • Severe coagulopathy or active use of anticoagulant medications
  • Contralateral phrenic nerve palsy or a diagnosis of severe chronic obstructive pulmonary disease (COPD)
  • History of chronic opioid consumption or neuropathic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start (Estimated)

August 14, 2026

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

December 28, 2026

Last Updated

July 31, 2026

Record last verified: 2026-07

Locations