- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06826846
Comparison of the Analgesic Effects of Continuous Versus Single-Shot Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
Comparison of the Analgesic Effects of Continuous Serratus Posterior Superior Intercostal Plane Block With Catheter Versus Single-Shot Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Goztepe Suleyman Yalcin City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18-80 years
- No bleeding diathesis
- Classified as ASA I-II-III
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Group 1: This patient group will not undergo any regional block
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Active Comparator: Group 2: Patients who will receive a single-shot serratus posterior superior plane block
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30 mL of 0.25% bupivacaine will be injected as single-shot block 20 mins prior to surgery
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Active Comparator: Group 3: Patients who will receive a continuous SPSIB with catheter
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Opioid Consumption
Time Frame: Postoperative 24 hours
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Patient-Controlled Analgesia (Tramadol)
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Postoperative 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Satisfaction (Likert scale)
Time Frame: Post surgery 24 hours
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Post surgery 24 hours
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Postoperative Pain Scores
Time Frame: Postoperative 24 hours
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Tha pain will be assessed with Numeric Rating Scale at 0, 30 minutes, 1, 4, 8, 12, and 24 hours.
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Postoperative 24 hours
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Postoperative Nausea and Vomiting Scale
Time Frame: 24 hours
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24 hours
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Perioperative Remifentanyl Consumption
Time Frame: Perioperative assessment
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Perioperative assessment
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Use of Rescue Analgesics in the Ward
Time Frame: 24 hours
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24 hours
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Collaborators and Investigators
Investigators
- Study Director: Senem Koruk, Goztepe Prof Dr Suleyman Yalcın City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOSPS001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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