Shoulder PainNCT06866054
Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery
A study testing SPSIPB block and Postoperative analgesia management in people with Shoulder Pain and Shoulder Injuries, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
Trial summary
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort and affects the functional outcome after surgery by preventing early rehabilitation. Various methods are used for postoperative pain control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain, Shoulder Injuries
- What is being tested?
- SPSIPB block and Postoperative analgesia management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Apr 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Who cannot join
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- patients who do not accept the procedure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bahadir Ciftci, Assoc Prof, MD contact
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Istanbul Medipol University
Istanbul, Bagcilar, 34000
Bahadir Ciftci, Assoc Prof, MD, bciftci@medipol.edu.tr
- Recruiting
KSU Faculty of Medicine Research Hospital
Kahramanmaraş, 46200
Bora Bilal, 03443003245, bbilal@ksu.edu.tr
About this study
Official title: Evaluation of the Effectiveness of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia Management in Patients Undergoing Arthroscopic Shoulder Surgery
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort and affects the functional outcome after surgery by preventing early rehabilitation. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use.
Serratus posterior superior interfascial plane block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. It has been reported that SPSIPB provides effective shoulder analgesia.
Read the detailed description
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort, prevents early rehabilitation, and affects the functional outcome after surgery. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use. Regional techniques can be used for postoperative pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided serratus posterior superior block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on the principle of injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases 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. Analgesia is provided by blocking these nerves with the SPS block. Tulgar et al. reported in their cadaver study that the spread of the serratus posterior superior interfascial plane block; staining in the superficial fascia of the trapezius muscle was observed only on the left side at the 7-10th intercostal levels, but not on the right. There was significant staining deep in the trapezius muscle on both sides. Both the surface and the skin of the rhomboid major were clearly stained, while only the skin of the rhomboid minor was stained; SPSP block will provide successful analgesia in procedures involving the thoracic region such as breast surgery, thoracic surgery, and shoulder surgery.
In this study, the investigators aim to evaluate the analgesic efficacy of SPSIPB by comparing the control group in patients who underwent arthroscopic shoulder surgery.
- Conditions
- Shoulder Pain, Shoulder Injuries
- Being tested
- SPSIPB block, Postoperative analgesia management
- Keywords
- Arthroscopic Shoulder Surgery, Postoperative analgesia management, serratus posterior superior intercostal plane block
- Medical subject headings
- Shoulder Pain, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPSIPB blockDrug
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 lateral decubitus position. 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.
Postoperative analgesia managementDrug
Patients will be administered ibuprofen 400 mgr 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 10 mcg bolus without infusion dose, 10 min lockout time, and 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.
| Study group | Role | What they receive |
|---|---|---|
| Group SPSIPB = SPSIPB group | Active comparator | SPSIPB will be performed Receives: Drug: SPSIPB block; Drug: Postoperative analgesia management |
| Group Control | Other | Conventional analgesia management will be performed Receives: Drug: Postoperative analgesia management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption (Fentanyl PCA)
The primary aim is to compare postoperative opioid consumption from the PCA device.
Measured: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary outcomes (3)
Pain scores (Numerical rating scale-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
Measured: 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.
Measured: Postoperative 24 hours period
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use
Measured: Postoperative 24 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start10 Apr 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. The first group is the serratus posterior superior intercostal plane block group. The second one is the control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bora Bilal, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866054
- Sponsor's protocol ID
- E-10840098-202.3.02-744
- Status last verified
- Jul 2025
- First submitted
- 4 Mar 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
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.
PubMed 36883093Ciftci 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.
PubMed 38240640Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.
PubMed 37272274Kulturoglu 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.
PubMed 38414179Turan EI, Isik S, Baydemir AE, Sahin AS. Serratus posterior superior intercostal plane block for postoperative analgesia in clavicle surgeries: new indications for a novel block. Minerva Anestesiol. 2024 Nov;90(11):1058-1060. doi: 10.23736/S0375-9393.24.18275-2. Epub 2024 Aug 5. No abstract available.
PubMed 39101308
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia Management in Patients Undergoing Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06866054
- Acronym / sponsor ID
- E-10840098-202.3.02-744
- Conditions
- Shoulder Pain, Shoulder Injuries
- Keywords
- Arthroscopic Shoulder Surgery, Postoperative analgesia management, serratus posterior superior intercostal plane block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort and affects the functional outcome after surgery by preventing early rehabilitation. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use.
Serratus posterior superior interfascial plane block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. It has been reported that SPSIPB provides effective shoulder analgesia.
Detailed description
Postoperative pain is a significant problem in patients undergoing arthroscopic shoulder surgery. This situation disrupts the patient's comfort, prevents early rehabilitation, and affects the functional outcome after surgery. Various methods are used for postoperative pain control. Intravenous opioid agents are one of the most commonly used analgesic techniques. However, opioids can cause undesirable side effects such as respiratory depression, sedation, constipation, allergic reactions, nausea, and vomiting. Therefore, alternative techniques are needed to reduce opioid use. Regional techniques can be used for postoperative pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided serratus posterior superior block (SPSIPB) is a novel interfascial plane block described by Tulgar et al in 2023. It is based on the principle of injection into the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in cases 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. Analgesia is provided by blocking these nerves with the SPS block. Tulgar et al. reported in their cadaver study that the spread of the serratus posterior superior interfascial plane block; staining in the superficial fascia of the trapezius muscle was observed only on the left side at the 7-10th intercostal levels, but not on the right. There was significant staining deep in the trapezius muscle on both sides. Both the surface and the skin of the rhomboid major were clearly stained, while only the skin of the rhomboid minor was stained; SPSP block will provide successful analgesia in procedures involving the thoracic region such as breast surgery, thoracic surgery, and shoulder surgery.
In this study, the investigators aim to evaluate the analgesic efficacy of SPSIPB by comparing the control group in patients who underwent arthroscopic shoulder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two models for this study. The first group is the serratus posterior superior intercostal plane block group. The second one is the control group.
| Arm | Type | Receives |
|---|---|---|
| Group SPSIPB = SPSIPB group | Active comparator | Drug: SPSIPB block, Drug: Postoperative analgesia managementSPSIPB will be performed |
| Group Control | Other | Drug: Postoperative analgesia managementConventional analgesia management will be performed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Key exclusion criteria (5 listed)
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- patients who do not accept the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPSIPB blockA 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 lateral decubitus position. 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. | Drug | Group SPSIPB = SPSIPB group |
| Postoperative analgesia managementPatients will be administered ibuprofen 400 mgr 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 10 mcg bolus without infusion dose, 10 min lockout time, and 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. | Drug | Group Control, Group SPSIPB = SPSIPB group |
Primary outcome
Opioid consumption (Fentanyl PCA)
Time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
The primary aim is to compare postoperative opioid consumption from the PCA device.
3 secondary outcomes
Pain scores (Numerical rating scale-NRS)
Time frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
Time frame: Postoperative 24 hours period
Adverse events
Time frame: Postoperative 24 hours period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Background: PubMed 36883093Tulgar 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.
- Background: PubMed 38240640Ciftci 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.
- Background: PubMed 37272274Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.
- Background: PubMed 38414179Kulturoglu 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.
- Background: PubMed 39101308Turan EI, Isik S, Baydemir AE, Sahin AS. Serratus posterior superior intercostal plane block for postoperative analgesia in clavicle surgeries: new indications for a novel block. Minerva Anestesiol. 2024 Nov;90(11):1058-1060. doi: 10.23736/S0375-9393.24.18275-2. Epub 2024 Aug 5. No abstract available.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahadir Ciftci, Assoc Prof, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPSIPB block and Postoperative analgesia management in people with Shoulder Pain and Shoulder Injuries, run by Kahramanmaras Sutcu Imam University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bora Bilal, Assoc Prof, MD (+905052354430, borabilal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (Fentanyl PCA) (time frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06866054, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.