- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07278050
Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block
Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia Management After Arthroscopic Shoulder Surgery: A Randomized Prospective Study
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 posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after shoulder surgery.
The aim of this study is to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.
Study Overview
Status
Conditions
Detailed 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 used for postoperative pain treatment. Opioids are one of the most preferred drugs among analgesic agents. Parenteral opioids are generally administered to patients after surgery. However, opioids have undesirable adverse events such as nausea, vomiting, itching, sedation, and respiratory depression (opioid-related adverse events).
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are commonly used. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.
US-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided.
In the cadaveric study of Tulgar et al., it was determined that the spread of the serratus posterior superior interfacial plane block, 7-10 intercostal levels on the left side, only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region, such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of the SPSP block for postoperative analgesia management after shoulder surgery.
This study aims to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery. The primary aim is to compare postoperative opioid consumption (fentanyl), and the secondary aim is to evaluate postoperative pain scores (NRS), adverse effects related to opioids (allergic reaction, nausea, vomiting).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bahadir Ciftci, Assoc Prof, MD
- Phone Number: +905343736865
- Email: bciftci@medipol.edu.tr
Study Contact Backup
- Name: Yunus Atalay, Prof, MD
Study Locations
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-
Bagcilar
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Istanbul, Bagcilar, Turkey (Türkiye), 34070
- Recruiting
- Istanbul Medipol University Hospital
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Contact:
- Bahadir Ciftci, MD
- Phone Number: +905325034428
- Email: bciftci@medipol.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Exclusion Criteria:
- 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 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 SPSIPB = SPSIPB group
SPSIPB will be performed
|
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 visualized with the third rib.
The in-plane technique will be used.
The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib.
The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle.
After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.
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 evaluation will be performed by an anesthesiologist blinded to the procedure.
|
|
Active Comparator: Group ESPB = ESPB group
ESPB will be performed
|
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 evaluation will be performed by an anesthesiologist blinded to the procedure.
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 injected deep into the erector spinae muscle fascia.
Following confirmation of the correct position of the needle, 30 mL %0.25 bupivacaine will be administered for the block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption (fentanyl)
Time Frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 hours
|
The primary aim is to compare postoperative opioid consumption
|
Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for rescue analgesia (meperidine)
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
|
Postoperative 24 hours period
|
|
Adverse events
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use
|
Postoperative 24 hours period
|
|
Pain scores (Numerical rating scores-NRS)
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
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
|
Collaborators and Investigators
Sponsor
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.
- Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.
- Kapukaya F, Ekinci M, Ciftci B, Atalay YO, Golboyu BE, Kuyucu E, Demiraran Y. Erector spinae plane block vs interscalene brachial plexus block for postoperative analgesia management in patients who underwent shoulder arthroscopy. BMC Anesthesiol. 2022 May 12;22(1):142. doi: 10.1186/s12871-022-01687-5.
- Zhang Y, Li H, Xu S, Guo R, Ma D, Wang Y. Understanding the Anatomy of Posterior Cervical Interfascial Space: Implications for Regional Blocks and Pain Management. A Narrative Review. Pain Ther. 2025 Aug;14(4):1203-1222. doi: 10.1007/s40122-025-00754-2. Epub 2025 Jun 16.
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 (Estimated)
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
- E-10840098-202.3.02-1405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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