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Clinical Trial NCT07278050 for Shoulder Pain, Shoulder Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block 60
Clinical Trial NCT07278050 is an interventional study for Shoulder Pain, Shoulder Disease that is recruiting. It started on 10 January 2026 with plans to enroll 60 participants. Led by Medipol University, it is expected to complete by 25 October 2026. The latest data from ClinicalTrials.gov was last updated on 14 January 2026.
Brief Summary
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and a shorter hospital stay. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are usually performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.
Ultrasound (US) guided serratus poster...
Show MoreDetailed Description
Postoperative pain is an important issue in patients who have undergone arthroscopic shoulder surgery. Pain causes a few problems: uncomfortable patients, negative outcomes, and longer rehabilitation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization, such as infection and thromboembolism, may be reduced. Various techniques may be u...Show More
Official Title
Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia Management After Arthroscopic Shoulder Surgery: A Randomized Prospective Study
Conditions
Shoulder PainShoulder DiseasePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- E-10840098-202.3.02-1405
NCT ID Number
Start Date (Actual)
2026-01-10
Last Update Posted
2026-01-14
Completion Date (Estimated)
2026-10-25
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Arthroscopic Shoulder Surgery
Postoperative analgesia management
serratus posterior superior intercostal plane block
Interscalene brachial plexus block
Postoperative analgesia management
serratus posterior superior intercostal plane block
Interscalene brachial plexus block
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGroup SPSIPB = SPSIPB group SPSIPB will be performed | Serratus posterior superior intercostal plane block A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the sitting position after surgery before extubation. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is...Show More Postoperative analgesia management Patients will be administered ibuprofen 400 mg IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including a 10 mcg bolus without an infusion dose, a 10-minute lockout time, and a 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 IV meperidine will be administered as a rescue analgesic. Postoperative patient ev...Show More |
Active ComparatorGroup ESPB = ESPB group ESPB will be performed | Erector spinae plane block The procedure will be performed with the patient in the supine position after surgery before extubation. ESPB will be performed. The US probe will be placed longitudinally 2-3 cm lateral to the T2 transverse process. The erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted in a caudo-cranial direction, and then, for correction, 5 ml of saline will be inject...Show More Postoperative analgesia management Patients will be administered ibuprofen 400 mg IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including a 10 mcg bolus without an infusion dose, a 10-minute lockout time, and a 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 IV meperidine will be administered as a rescue analgesic. Postoperative patient ev...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Opioid consumption (fentanyl) | The primary aim is to compare postoperative opioid consumption | Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 hours |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pain scores (Numerical rating scores-NRS) | The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded | Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours |
Need for rescue analgesia (meperidine) | The secondary aim is to compare rescue analgesia used in the postoperative 24 h. | Postoperative 24 hours period |
Adverse events | The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use | Postoperative 24 hours period |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic shoulder surgery under general anesthesia
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who do not accept the procedure
Study Responsible Party
Bahadir Ciftci, Principal Investigator, Principal Investigator, Medipol University
Study Central Contact
Contact: Bahadir Ciftci, Assoc Prof, MD, +905343736865, [email protected]
Contact: Yunus Atalay, Prof, MD
1 Study Locations in 1 Countries
Bagcilar
Istanbul Medipol University Hospital, Istanbul, Bagcilar, 34070, Turkey (Türkiye)
Bahadir Ciftci, MD, Contact, +905325034428, [email protected]
Recruiting