Arthroscopic Shoulder SurgeryNCT06826846
Comparison of the Analgesic Effects of Catheter-Based Versus Single-Shot Serratus Posterior Superior Intercostal Plane Block in Arthroscopic Shoulder Surgery
A study testing Serratus posterior superior intercostal plane block (single-shot) and Serratus posterior superior intercostal plane block (catheter-based intermittent bolus) in people with Arthroscopic Shoulder Surgery, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients undergoing arthroscopic shoulder surgery often experience moderate to severe postoperative pain. Various medical treatments are employed to provide analgesia for these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroscopic Shoulder Surgery
- What is being tested?
- Serratus posterior superior intercostal plane block (single-shot) and Serratus posterior superior intercostal plane block (catheter-based intermittent bolus)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-80 years
- No bleeding diathesis
- Classified as ASA I-II-III
Who cannot join
- Patients who do not provide consent
- Patients with coagulopathy
- History of allergy or intoxication to local anesthetic agents
- Patients with advanced organ failure
- History of neuropathic disease
- Patients with mental retardation
Show all 10Show fewer
- Presence of infection at the injection site
- Conditions in which regional anesthesia is contraindicated
- Pediatric patients and those over 80 years of age
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: Comparison of the Analgesic Effects of Catheter-Based and Single-Shot Serratus Posterior Superior Intercostal Plane Block Versus No Block in Arthroscopic Shoulder Surgery
Patients undergoing arthroscopic shoulder surgery often experience moderate to severe postoperative pain. Various medical treatments are employed to provide analgesia for these patients. The advancement of regional anesthesia techniques has made possible to both reduce the use of narcotic analgesics and provide long-term pain management benefits.
The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) was first described in 2023 by Serkan Tulgar et al. Cadaveric studies and dermatomal analyses in patients have demonstrated its ability to provide analgesia in the back, neck, shoulder, axilla, and lateral thoracic regions.
Read more
Even though patients undergoing shoulder surgery benefit from the block; once the duration of a single-shot block wears off, they may experience severe pain again. The aim of this study is to investigate the analgesic effects of a single-shot SPSIPB compared to catheter-based SPSIPB with intermittent postoperative bolus administration provided by placing a catheter in this region.
The hypothesis of this study: In arthroscopic shoulder surgery, the intermittent bolus administration of the serratus posterior superior intercostal plane block using a catheter will result in lower pain scores, reduced opioid consumption, and improved patient satisfaction compared to single-shot application.
- Conditions
- Arthroscopic Shoulder Surgery
- Being tested
- Serratus posterior superior intercostal plane block (single-shot), Serratus posterior superior intercostal plane block (catheter-based intermittent bolus)
- Keywords
- serratus posterior superior intercostal plane block, shoulder arthroscopy, regional anesthesia, plane block, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane block (single-shot)Other
30 mL of 0.25% bupivacaine will be injected as single-shot block 20 mins prior to surgery
Serratus posterior superior intercostal plane block (catheter-based intermittent bolus)Other
Patients in this group will receive an ultrasound-guided serratus posterior superior intercostal plane block with 30 mL of 0.25% bupivacaine before surgery. Following the initial block, a catheter will be placed in the serratus posterior superior intercostal plane. Postoperatively, 0.25% bupivacaine at a dose of 30 mL will be administered through the catheter as an intermittent bolus every 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: This patient group will not undergo any regional block | No intervention | Not described |
| Group 2: Patients who will receive a single-shot serratus posterior superior plane block | Active comparator | Not described Receives: Other: Serratus posterior superior intercostal plane block (single-shot) |
| Group 3: Catheter-based SPSIPB with intermittent postoperative bolus administration | Active comparator | Not described Receives: Other: Serratus posterior superior intercostal plane block (catheter-based intermittent bolus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Consumption
Patient-Controlled Analgesia (Tramadol)
Measured: Postoperative 24 hours
Secondary outcomes (5)
Postoperative Pain Scores
Tha pain will be assessed with Numeric Rating Scale at 0, 30 minutes, 1, 4, 8, 12, and 24 hours.
Measured: Postoperative 24 hours
Patient Satisfaction (Likert scale)
Measured: Post surgery 24 hours
Postoperative Nausea and Vomiting Scale
Measured: 24 hours
Perioperative Remifentanyl Consumption
Measured: Perioperative assessment
Use of Rescue Analgesics in the Ward
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Mar 2025
- Primary completion15 Sep 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKER YALCIN, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Senem Koruk, Study director, Goztepe Prof Dr Suleyman Yalcın City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826846
- Sponsor's protocol ID
- AOSPS001
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effects of Catheter-Based and Single-Shot Serratus Posterior Superior Intercostal Plane Block Versus No Block in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06826846
- Acronym / sponsor ID
- AOSPS001
- Conditions
- Arthroscopic Shoulder Surgery
- Keywords
- serratus posterior superior intercostal plane block, shoulder arthroscopy, regional anesthesia, plane block, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 14 Feb 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.
Patients undergoing arthroscopic shoulder surgery often experience moderate to severe postoperative pain. Various medical treatments are employed to provide analgesia for these patients. The advancement of regional anesthesia techniques has made possible to both reduce the use of narcotic analgesics and provide long-term pain management benefits.
The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) was first described in 2023 by Serkan Tulgar et al. Cadaveric studies and dermatomal analyses in patients have demonstrated its ability to provide analgesia in the back, neck, shoulder, axilla, and lateral thoracic regions.
Even though patients undergoing shoulder surgery benefit from the block; once the duration of a single-shot block wears off, they may experience severe pain again. The aim of this study is to investigate the analgesic effects of a single-shot SPSIPB compared to catheter-based SPSIPB with intermittent postoperative bolus administration provided by placing a catheter in this region.
The hypothesis of this study: In arthroscopic shoulder surgery, the intermittent bolus administration of the serratus posterior superior intercostal plane block using a catheter will result in lower pain scores, reduced opioid consumption, and improved patient satisfaction compared to single-shot application.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: This patient group will not undergo any regional block | No intervention | – |
| Group 2: Patients who will receive a single-shot serratus posterior superior plane block | Active comparator | Other: Serratus posterior superior intercostal plane block (single-shot) |
| Group 3: Catheter-based SPSIPB with intermittent postoperative bolus administration | Active comparator | Other: Serratus posterior superior intercostal plane block (catheter-based intermittent bolus) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18-80 years
- No bleeding diathesis
- Classified as ASA I-II-III
Key exclusion criteria (10 listed)
- Patients who do not provide consent
- Patients with coagulopathy
- History of allergy or intoxication to local anesthetic agents
- Patients with advanced organ failure
- History of neuropathic disease
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 |
|---|---|---|
| Serratus posterior superior intercostal plane block (single-shot)30 mL of 0.25% bupivacaine will be injected as single-shot block 20 mins prior to surgery | Other | Group 2: Patients who will receive a single-shot serratus posterior superior plane block |
| Serratus posterior superior intercostal plane block (catheter-based intermittent bolus)Patients in this group will receive an ultrasound-guided serratus posterior superior intercostal plane block with 30 mL of 0.25% bupivacaine before surgery. Following the initial block, a catheter will be placed in the serratus posterior superior intercostal plane. Postoperatively, 0.25% bupivacaine at a dose of 30 mL will be administered through the catheter as an intermittent bolus every 8 hours. | Other | Group 3: Catheter-based SPSIPB with intermittent postoperative bolus administration |
Primary outcome
Postoperative Opioid Consumption
Time frame: Postoperative 24 hours
Patient-Controlled Analgesia (Tramadol)
5 secondary outcomes
Postoperative Pain Scores
Time frame: Postoperative 24 hours
Patient Satisfaction (Likert scale)
Time frame: Post surgery 24 hours
Postoperative Nausea and Vomiting Scale
Time frame: 24 hours
Perioperative Remifentanyl Consumption
Time frame: Perioperative assessment
Use of Rescue Analgesics in the Ward
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- 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. This study is not recruiting at the moment.
Senem Koruk study director
Goztepe Prof Dr Suleyman Yalcın 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 Serratus posterior superior intercostal plane block (single-shot) and Serratus posterior superior intercostal plane block (catheter-based intermittent bolus) in people with Arthroscopic Shoulder Surgery, run by Goztepe Prof Dr Suleyman Yalcın 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 1 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Opioid Consumption (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.