NCT07259785

Brief Summary

The aim is to compare the postoperative analgesic and hemidiaphragmatic effects of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) versus CostoClavicular Brachial Plexus Block (CCBPB) in patients undergoing arthroscopic shoulder surgery.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

November 1, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

November 21, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

postoperative painshoulder arthroscopyregional anesthesiacostoclavicular brachial plexus blockserratus posterior superior intercostal plane 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)

  • Total tramadol consumption

    Postoperative 24 hours

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

    Preoperatively and Postoperatively at 24th hour

Study Arms (2)

SPSIPB

ACTIVE COMPARATOR

SPSIPB will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in lateral position.The ultrasound probe was placed 2-3 cm medial to the scapular spine to visualize the trapezius, rhomboid major, and serratus posterior superior muscles. At the level of the 2nd-3rd ribs, a needle was advanced into the plane between the serratus posterior superior muscle and the ribs. After confirming the placement of the needle tip with negative aspiration, 30 mL of 0.25% bupivacaine was injected. The block was performed unilaterally, targeting the shoulder undergoing surgery.

Procedure: Serratus posterior superior intercostal plane block

CCBPB

ACTIVE COMPARATOR

CCBPB 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

Interventions

30 mL of 0.25% bupivacaine

SPSIPB

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 unilateral elective arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) score 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

November 21, 2025

First Posted

December 2, 2025

Study Start

November 1, 2025

Primary Completion

February 25, 2026

Study Completion

March 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations