NCT06973447

Brief Summary

The aim is to compare the postoperative analgesic and hemidiaphragmatic effects of Anterior SupraScapular Nerve Block (ASSNB) and InfraClavicular Brachial Plexus Block (ICBPB) combination versus CostoClavicular Brachial Plexus Block (CCBPB) in patients undergoing shoulder arthroscopic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

May 7, 2025

Last Update Submit

December 25, 2025

Conditions

Keywords

postoperative painshoulder arthroscopyregional anesthesiacostoclavicular brachial plexus blockinfraclavicular brachial plexus blockanterior suprascapular nerve block

Outcome Measures

Primary Outcomes (2)

  • Numeric Rating Scale (NRS) Scores

    Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

    Postoperative 24 hours

  • Diaphragmatic Excursion Difference

    Ipsilateral diaphragmatic excursions will be measured both preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring). A diaphragmatic excursion change of up to 25% indicates no nerve involvement, a change between 25%-75% indicates partial involvement, and a change exceeding 75% indicates complete involvement of the phrenic nerve.

    Preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring)

Secondary Outcomes (2)

  • Quality of Recovery-15 Patient Survey (QoR-15)

    Preoperatively and Postoperatively at 24th hour

  • Total tramadol consumption

    Postoperative 24 hours

Study Arms (2)

Combined ASSNB and ICBPB

ACTIVE COMPARATOR

For this group, ASSNB and ICBPB blocks will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in supine position. For ICBPB, a high frequency linear transducer USG is placed over the lateral infraclavicular fossa in a sagittal orientation medial to the coracoid process and caudal to the clavicle. The block needle is inserted in-plane from a cephalad-to-caudal direction, just inferior to the clavicle to pass through the pectoralis major and minor muscles, aiming toward the posterior aspect of the axillary artery. 15 mL of 0.25% bupivacaine is administered. For ASSNB, the transducer is positioned in a sagittal oblique orientation over the supraclavicular fossa to image the subclavian artery and the brachial plexus. While tracing the plexus craniocaudally, the suprascapular nerve is identified. The needle is advanced in-plane from posterior to anterior. 10 mL of 0.25% bupivacaine is administered.

Procedure: Anterior suprascapular nerve block (ASSNB)Procedure: Infraclavicular Brachial Plexus Block (ICBPB)

CCBPB

ACTIVE COMPARATOR

For this group, CCBPC will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in supine position. For CCBPB, a high frequency linear transducer of the USG is placed in the medial infraclavicular fossa parallel and next to the clavicle to identify the axillary artery. The transducer is then tilted cephalad to image the brachial plexus and the artery in a perpendicular orientation between the subclavius muscle and the serratus anterior. The needle is advanced in-plane in a lateral-to-medial direction, adjusting the angle to reach the space in between the three cords. 15 mL of 0.25% bupivacaine is administered.

Procedure: Costoclavicular brachial plexus block (CCBPB)

Interventions

10 mL of 0.25% bupivacaine

Combined ASSNB and ICBPB

15 mL of 0.25% bupivacaine

Combined ASSNB and ICBPB

15 mL of 0.25% bupivacaine

CCBPB

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients older than 18 years of age who underwent arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

You may not qualify if:

  • patients who did not give consent,
  • patients with coagulopathy,
  • patients with signs of infection at the block application site,
  • patients using anticoagulants,
  • patients with local anesthetic drug allergies,
  • patients with unstable hemodynamics,
  • patients who could not cooperate during postoperative pain assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Oğuz Gündoğdu

    Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 15, 2025

Study Start

January 30, 2024

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations