- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394673
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery (SPSIP)
Postoperative Analgesic Efficacy of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Most patients undergoing arthroscopic shoulder surgery report pain in the postoperative period. Pain management remains a significant concern in patient management, as it affects surgical costs, postoperative mobility, length of hospital stay, patient satisfaction, and surgical outcomes. Multimodal analgesia is recommended for the management of postoperative pain. Regional analgesia is an important component of multimodal analgesia.
The serratus posterior superior intercostal plane (SPSIP) block is a novel regional analgesia technique described in 2023. SPSIP has been reported to provide near-complete sensory blockade in the posterior neck, shoulder, and hemithorax regions.
The main objective of this study is to investigate the effectiveness of SPSIP block in patients undergoing arthroscopic shoulder surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mursel Ekinci, Assoc prof, MD
- Phone Number: +905067137596
- Email: drmurselekinci@gmail.com
Study Contact Backup
- Name: Merih Yıldız Eglen, MD
- Phone Number: +905059340629
- Email: Meriheg@yahoo.com
Study Locations
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Bursa, Turkey (Türkiye), 16110
- Recruiting
- Bursa City Hospital
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Contact:
- Merih Yildiz Eglen, MD
- Phone Number: +905059340629
- Email: meriheg@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group SPSIP
Group SPSIP Participants in this arm will receive an ultrasound-guided serratus posterior plane block .
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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. |
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No Intervention: Group Control
No block procedures will be performed on patients in this arm
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative 48-Hour PCA Opioid Consumption
Time Frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
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Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams(mg)
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Postoperative 0-8, 8-16, 16-24, 24-48 intervals
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
QoR-15 Recovery Score
Time Frame: Postoperative 24th and 48th hours
|
The investigators will use the Turkish version of Quality of Recovery (QoR) / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) Able to breathe easily Been able to enjoy food Feeling rested Have had a good sleep Able to look after personal toilet and hygiene unaided Able to communicate with Getting support from hospital doctors and nurses Able to return to work or usual home activities Feeling comfortable and in control Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) Moderate pain Severe pain Nausea or vomiting Feeling worried or anxious Feeling sad or depressed |
Postoperative 24th and 48th hours
|
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Block and Opioid-Related Adverse Effects and Complications
Time Frame: Postoperative 48-Hours
|
Block- and opioid-related adverse effects and complications, including but not limited to local anesthetic toxicity, hematoma, infection, nerve injury, nausea, vomiting, pruritus, sedation, and respiratory depression, will be recorded
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Postoperative 48-Hours
|
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Dynamic and static NRS scores
Time Frame: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
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Numeric Rating Scale (NRS) (0-10 0: No pain 10: most pain felt) pain scores at rest or movement at predefined postoperative hours
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0, 2, 4, 8, 16, 24, and 48 hours postoperatively
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Total rescue analgesic dose
Time Frame: Postoperative 24th and 48th hours
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Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered as
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Postoperative 24th and 48th hours
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Time of first request for rescue analgesia,
Time Frame: Postoperative 48-Hours
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Despite the use of patient-controlled analgesia (PCA), if the Numeric Rating Scale (NRS) score is ≥4 at any time point, 0.5 mg/kg intravenous meperidine will be administered.
The time will be recorded.
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Postoperative 48-Hours
|
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Length of Hospital Stay
Time Frame: the day of surgery, the day of discharge from the hospital
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Number of days spent in hospital after surgery
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the day of surgery, the day of discharge from the hospital
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Perioperative Remifentanil infusion dose
Time Frame: Start time: Start of anesthesia administration End time: Termination of anesthesia administration
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The amount of remifentanil administered in micrograms during general anesthesia
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Start time: Start of anesthesia administration End time: Termination of anesthesia administration
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Merih Yıldız Eglen, MD, Bursa City Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
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
- BursaCityHOS 4
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
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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