NCT06826846

Brief Summary

Patients undergoing arthroscopic shoulder surgery often experience moderate to severe postoperative pain. Various medical treatments are employed to provide analgesia for these patients. The advancement of regional anesthesia techniques has made possible to both reduce the use of narcotic analgesics and provide long-term pain management benefits. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) was first described in 2023 by Serkan Tulgar et al. Cadaveric studies and dermatomal analyses in patients have demonstrated its ability to provide analgesia in the back, neck, shoulder, axilla, and lateral thoracic regions. Even though patients undergoing shoulder surgery benefit from the block; once the duration of a single-shot block wears off, they may experience severe pain again. The aim of this study is to investigate the analgesic effects of a single-shot SPSIPB compared to continuous infusion provided by placing a catheter in this region. The hypothesis of this study: In arthroscopic shoulder surgery, the continuous application of the serratus posterior superior intercostal plane block using a catheter will result in lower pain scores, reduced opioid consumption, and improved patient satisfaction compared to single-shot application.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

January 2, 2026

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

February 10, 2025

Last Update Submit

December 28, 2025

Conditions

Keywords

serratus posterior superior intercostal plane blockshoulder arthroscopyregional anesthesiaplane blockpostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Opioid Consumption

    Patient-Controlled Analgesia (Tramadol)

    Postoperative 24 hours

Secondary Outcomes (5)

  • Postoperative Pain Scores

    Postoperative 24 hours

  • Patient Satisfaction (Likert scale)

    Post surgery 24 hours

  • Postoperative Nausea and Vomiting Scale

    24 hours

  • Perioperative Remifentanyl Consumption

    Perioperative assessment

  • Use of Rescue Analgesics in the Ward

    24 hours

Study Arms (3)

Group 1: This patient group will not undergo any regional block

NO INTERVENTION

Group 2: Patients who will receive a single-shot serratus posterior superior plane block

ACTIVE COMPARATOR
Other: Serratus posterior superior intercostal plane block (single-shot)

Group 3: Patients who will receive a continuous SPSIB with catheter

ACTIVE COMPARATOR
Other: Serratus posterior superior intercostal plane block (catheter)

Interventions

30 mL of 0.25% bupivacaine will be injected as single-shot block 20 mins prior to surgery

Group 2: Patients who will receive a single-shot serratus posterior superior plane block

In addition to administration of 30 mL of 0.25% bupivacaine prior to surgery, a catheter will be placed in the area to administer bolus of 1 mg/kg of 0.25% bupivacaine every 8 hours postoperatively.

Group 3: Patients who will receive a continuous SPSIB with catheter

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18-80 years
  • No bleeding diathesis
  • Classified as ASA I-II-III

You may not qualify if:

  • Patients who do not provide consent
  • Patients with coagulopathy
  • History of allergy or intoxication to local anesthetic agents
  • Patients with advanced organ failure
  • History of neuropathic disease
  • Patients with mental retardation
  • Presence of infection at the injection site
  • Conditions in which regional anesthesia is contraindicated
  • Pediatric patients and those over 80 years of age
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goztepe Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Catheters

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Senem Koruk

    Goztepe Prof Dr Suleyman Yalcın City Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Resident, M.D.

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 14, 2025

Study Start

March 1, 2025

Primary Completion

September 15, 2025

Study Completion

October 10, 2025

Last Updated

January 2, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations