Postoperative Pain, AcuteSPSIPNCT07394673
Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery
A study testing Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP) in people with Postoperative Pain, Acute and Shoulder Pain, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Acute, Shoulder Pain, Serratus Posterior Superior Intercostal Plane Block
- What is being tested?
- Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2026to 20 Nov 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy or lactation
- Diabetes mellitus
- Renal or hepatic impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, Bursa, 16110
Merih Yildiz Eglen, MD, +905059340629, meriheg@yahoo.com
About this study
Official title: Postoperative Analgesic Efficacy of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery.
Read the 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.
- Conditions
- Postoperative Pain, Acute, Shoulder Pain, Serratus Posterior Superior Intercostal Plane Block
- Being tested
- Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP)
- Keywords
- postoperative analgesia, shoulder arthroscopy, serratus posterior superior intercostal plane block
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group SPSIP | Active comparator | Group SPSIP Participants in this arm will receive an ultrasound-guided serratus posterior plane block . Receives: Procedure: Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP) |
| Group Control | No intervention | No block procedures will be performed on patients in this arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 48-Hour PCA Opioid Consumption
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams(mg)
Measured: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Secondary outcomes (7)
QoR-15 Recovery Score
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
Measured: Postoperative 24th and 48th hours
Dynamic and static NRS scores
Numeric Rating Scale (NRS) (0-10 0: No pain 10: most pain felt) pain scores at rest or movement at predefined postoperative hours
Measured: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
Total rescue analgesic dose
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
Measured: Postoperative 24th and 48th hours
Time of first request for rescue analgesia,
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.
Measured: Postoperative 48-Hours
Length of Hospital Stay
Number of days spent in hospital after surgery
Measured: the day of surgery, the day of discharge from the hospital
Block and Opioid-Related Adverse Effects and Complications
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
Measured: Postoperative 48-Hours
Perioperative Remifentanil infusion dose
The amount of remifentanil administered in micrograms during general anesthesia
Measured: Start time: Start of anesthesia administration End time: Termination of anesthesia administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start20 Feb 2026
- Primary completion20 Sep 2026
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies 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
- Active Comparator: Group SPSIP: Participants in this arm will receive an ultrasound-guided serratus posterior superior intercostal plane block before the surgery. Patients will be taken to the operating room after sensory and motor block assessment. Control group: No block procedures will be performed on patients in this arm. Both groups will receive general anesthesia using the standard anesthesia method; induction with lidocaine, propofol, fentanyl, and rocuronium. Maintenance will be provided by inhalation anesthesia and remifentanil infusion. Before the end of surgery, all patients will receive paracetamol, Tramadol, and Tenoxicam intravenously as standard postoperative analgesia. After surgery, patients will be extubated and taken to the post-anesthesia care unit. Patient-controlled analgesia devices will be attached to all patients in the post-anesthesia care unit.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merih Yıldız Eglen, Bursa City Hospital
- Investigators
- Merih Yıldız Eglen, MD, Principal investigator, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394673
- Sponsor's protocol ID
- BursaCityHOS 4
- Acronym
- SPSIP
- Status last verified
- Nov 2026
- First submitted
- 29 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38343684Kulturoglu 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 38414179Tulgar 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 36883093
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Efficacy of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT07394673
- Acronym / sponsor ID
- SPSIP / BursaCityHOS 4
- Conditions
- Postoperative Pain, Acute, Shoulder Pain, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- postoperative analgesia, shoulder arthroscopy, serratus posterior superior intercostal plane block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 6 Feb 2026 (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.
This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Active Comparator: Group SPSIP: Participants in this arm will receive an ultrasound-guided serratus posterior superior intercostal plane block before the surgery. Patients will be taken to the operating room after sensory and motor block assessment. Control group: No block procedures will be performed on patients in this arm. Both groups will receive general anesthesia using the standard anesthesia method; induction with lidocaine, propofol, fentanyl, and rocuronium. Maintenance will be provided by inhalation anesthesia and remifentanil infusion. Before the end of surgery, all patients will receive paracetamol, Tramadol, and Tenoxicam intravenously as standard postoperative analgesia. After surgery, patients will be extubated and taken to the post-anesthesia care unit. Patient-controlled analgesia devices will be attached to all patients in the post-anesthesia care unit.
| Arm | Type | Receives |
|---|---|---|
| Group SPSIP | Active comparator | Procedure: Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP)Group SPSIP Participants in this arm will receive an ultrasound-guided serratus posterior plane block . |
| Group Control | No intervention | –No block procedures will be performed on patients in this arm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP)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. | Procedure or surgery | Group SPSIP |
Primary outcome
Postoperative 48-Hour PCA Opioid Consumption
Time frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals
Total amount of opioid delivered by the patient-controlled analgesia (PCA) device during the first 48 hours after surgery, recorded in milligrams(mg)
7 secondary outcomes
QoR-15 Recovery Score
Time frame: Postoperative 24th and 48th hours
Dynamic and static NRS scores
Time frame: 0, 2, 4, 8, 16, 24, and 48 hours postoperatively
Total rescue analgesic dose
Time frame: Postoperative 24th and 48th hours
Time of first request for rescue analgesia,
Time frame: Postoperative 48-Hours
Length of Hospital Stay
Time frame: the day of surgery, the day of discharge from the hospital
Block and Opioid-Related Adverse Effects and Complications
Time frame: Postoperative 48-Hours
Perioperative Remifentanil infusion dose
Time frame: Start time: Start of anesthesia administration End time: Termination of anesthesia administration
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 3 Nov 2026.
- Background: PubMed 38343684Avci 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.
- 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 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.
- Individual participant dataSharing planned: No
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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.
Merih Yıldız Eglen, MD principal investigator
Bursa City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group SPSIP: Serratus Posterior Superior İntercostal Plane Block (SPSIP) in people with Postoperative Pain, Acute and Shoulder Pain, run by Bursa City Hospital at 1 site 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 4 inclusion and 9 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Mursel Ekinci, Assoc prof, MD (+905067137596, drmurselekinci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative 48-Hour PCA Opioid Consumption (time frame: Postoperative 0-8, 8-16, 16-24, 24-48 intervals). 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 NCT07394673, which also lists 3 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 3 Nov 2026.