NCT07394673

Brief Summary

This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress38%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

January 29, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
14 days until next milestone

Study Start

First participant enrolled

February 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

January 29, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

postoperative analgesiashoulder arthroscopyserratus posterior superior intercostal plane block

Outcome Measures

Primary Outcomes (1)

  • Postoperative 48-Hour PCA Opioid Consumption

    Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams(mg)

    Postoperative 0-8, 8-16, 16-24, 24-48 intervals

Secondary Outcomes (7)

  • QoR-15 Recovery Score

    Postoperative 24th and 48th hours

  • Dynamic and static NRS scores

    0, 2, 4, 8, 16, 24, and 48 hours postoperatively

  • Total rescue analgesic dose

    Postoperative 24th and 48th hours

  • Time of first request for rescue analgesia,

    Postoperative 48-Hours

  • Length of Hospital Stay

    the day of surgery, the day of discharge from the hospital

  • +2 more secondary outcomes

Study Arms (2)

Group SPSIP

ACTIVE COMPARATOR

Group SPSIP Participants in this arm will receive an ultrasound-guided serratus posterior plane block .

Procedure: Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP)

Group Control

NO INTERVENTION

No block procedures will be performed on patients in this arm

Interventions

Serratus Posterior Superior İntercostal Plane (SPSIP) Block will be performed before the surgery in seated position, under standard sterilization conditions.A linear ultrasound probe will be placed in the sagittal plane along the medial border of the scapula, and the second and third ribs, relevant muscles, and the pleura will be identified. The needle will be advanced into the interfascial plane between the serratus posterior superior and intercostal muscles. After confirmation with salin injection , the block will be performed by injecting 30 mL of 0.25% bupivacaine, and the cranio-caudal spread will be visualized under ultrasound.

Group SPSIP

Eligibility Criteria

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

You may qualify if:

  • Classified as American Society of Anesthesiologists (ASA) physical status I-II-III
  • Scheduled for elective shoulder arthroscopy surgery
  • Surgery performed under general anesthesia
  • Provision of written informed consent

You may not qualify if:

  • Use of anticoagulant or antiplatelet medications
  • Presence of bleeding diathesis or coagulation disorders
  • Known allergy or hypersensitivity to local anesthetics or opioid medications
  • Infection or history of previous surgery at the planned block site
  • Alcohol or drug dependence
  • Cognitive impairment preventing reliable pain assessment using the NRS
  • Pregnancy or lactation
  • Diabetes mellitus
  • Renal or hepatic impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa City Hospital

Bursa, 16110, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.

    PMID: 38343684BACKGROUND
  • Kulturoglu G, Altinsoy S, Ozguner Y, Cataroglu CK. Novel Serratus Posterior Superior Intercostal Plane Block Provided Satisfactory Analgesia after Breast Cancer Surgery: Two Case Reports. Turk J Anaesthesiol Reanim. 2024 Feb 28;52(1):33-35. doi: 10.4274/TJAR.2024.231431.

    PMID: 38414179BACKGROUND
  • Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

    PMID: 36883093BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeShoulder Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthralgiaJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Merih Yıldız Eglen, MD

    Bursa City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mursel Ekinci, Assoc prof, MD

CONTACT

Merih Yıldız Eglen, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Active Comparator: Group SPSIP: Participants in this arm will receive an ultrasound-guided serratus posterior superior intercostal plane block before the surgery. Patients will be taken to the operating room after sensory and motor block assessment. Control group: No block procedures will be performed on patients in this arm. Both groups will receive general anesthesia using the standard anesthesia method; induction with lidocaine, propofol, fentanyl, and rocuronium. Maintenance will be provided by inhalation anesthesia and remifentanil infusion. Before the end of surgery, all patients will receive paracetamol, Tramadol, and Tenoxicam intravenously as standard postoperative analgesia. After surgery, patients will be extubated and taken to the post-anesthesia care unit. Patient-controlled analgesia devices will be attached to all patients in the post-anesthesia care unit.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 6, 2026

Study Start

February 20, 2026

Primary Completion (Estimated)

April 20, 2026

Study Completion (Estimated)

July 20, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations