NCT07311096

Brief Summary

This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and serratus posterior superior intercostal plane block (SPSIP) for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery. The primary outcome is total 24-hour opioid consumption. Secondary outcomes include pain scores, hemidiaphragmatic paresis incidence and severity, duration of analgesia, and changes in lung function. Participants are randomized into ISB or SPSIP groups; blocks are performed under ultrasound guidance. Postoperative pain is managed with patient controlled analgesia(PCA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

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

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 16, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

Postoperative painAnalgesiaRegional AnesthesiaInterscalene brachial plexus blockSerratus posterior superior plane block

Outcome Measures

Primary Outcomes (1)

  • Total 24-Hour Postoperative Opioid Consumption

    Total intravenous opioid consumption recorded for each patient during the first 24 hours after arthroscopic shoulder surgery, including any rescue analgesia administered.

    0-24 hours postoperatively

Secondary Outcomes (4)

  • Incidence and Severity of Hemidiaphragmatic Paresis

    Pre-block and 30 minutes post-block

  • Duration of Analgesia

    Time interval from block completion to initiation of IV PCA fentanyl in each patient

  • Pulmonary Function Changes (FEV1)

    Pre-block and 30 minutes post-block

  • Pulmonary Function Changes (FVC)

    Pre-block and 30 minutes post-block

Study Arms (2)

Interscalene Brachial Plexus Block (ISB)

EXPERIMENTAL

Patients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine.

Procedure: Interscalene Brachial Plexus Block (ISB)

Serratus Posterior Superior Intercostal Plane Block

EXPERIMENTAL

Patients will receive SPSIP block under ultrasound guidance using 30 ml 0.25% bupivacaine

Procedure: Serratus Posterior Superior Intercostal Plane Block (SPSIP)

Interventions

Patients receive ultrasound-guided ISB before arthroscopic shoulder surgery. 15 ml of 0.25% bupivacaine is injected using a 22 Gauge 50 mm needle with posterior in-plane approach, targeting C5-C6 roots.

Interscalene Brachial Plexus Block (ISB)

Patients receive ultrasound-guided SPSIP interfascial block in sitting position before surgery. Using a 22 Gauge 10 mm needle, 30 ml of 0.25% bupivacaine is injected between serratus posterior muscle and second rib.

Serratus Posterior Superior Intercostal Plane Block

Eligibility Criteria

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

You may qualify if:

  • Agreeing to participate in the study
  • The American Society of Anesthesiologists I-III
  • Scheduled for elective unilateral arthroscopic shoulder surgery

You may not qualify if:

  • Refusal to participate in the study
  • Allergy to the medications to be used
  • History of serious heart, kidney or liver disease
  • Neurological deficits or neuropathy
  • History of anticoagulant use
  • Pre-existing operative respiratory dysfunction
  • Having chronic shoulder pain
  • Being about to undergo open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzurum Regional Training Research Hospital

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (3)

  • Kumari P, Kumar A, Aliyar R, Sinha L. Continuous serratus posterior superior intercostal plane block for postoperative analgesia in thoracotomy. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101570. doi: 10.1016/j.accpm.2025.101570. Epub 2025 Jun 14. No abstract available.

    PMID: 40523524BACKGROUND
  • Dogan G, Kucuk O, Kayir S, Dal GC, Ciftci B, Zengin M, Alagoz A. Serratus posterior superior intercostal plane block versus thoracic paravertebral block for pain management after video-assisted thoracoscopic surgery: a randomized prospective study. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844647. doi: 10.1016/j.bjane.2025.844647. Epub 2025 Jun 3.

    PMID: 40473018BACKGROUND
  • Ozen V, Turan EI, Alver S, Ciftci B, Cakir I, Sahin AS. Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in a Pediatric Patient Undergoing Lobectomy: A Case Report. A A Pract. 2025 May 27;19(5):e01988. doi: 10.1213/XAA.0000000000001988. eCollection 2025 May 1.

    PMID: 40421887BACKGROUND

MeSH Terms

Conditions

Shoulder PainPain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Ömer Doymus, MD

    Erzurum Regional Training & Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The anesthesiologist performing the blocks is aware of the group allocation; all other staff and outcome assessors are blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2025

First Posted

December 30, 2025

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations