Shoulder PainNCT07311096
Interscalene Block Versus Serratus Posterior Superior Intercostal Plane Block for Arthroscopic Shoulder Surgery
A study testing Interscalene Brachial Plexus Block (ISB) and Serratus Posterior Superior Intercostal Plane Block (SPSIP) in people with Shoulder Pain, run by Erzurum Regional Training & Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and serratus posterior superior intercostal plane block (SPSIP) for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery. The primary outcome is total 24-hour opioid consumption. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Interscalene Brachial Plexus Block (ISB) and Serratus Posterior Superior Intercostal Plane Block (SPSIP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 15 Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the study
- The American Society of Anesthesiologists I-III
- Scheduled for elective unilateral arthroscopic shoulder surgery
Who cannot join
- Refusal to participate in the study
- Allergy to the medications to be used
- History of serious heart, kidney or liver disease
- Neurological deficits or neuropathy
- History of anticoagulant use
- Pre-existing operative respiratory dysfunction
- Having chronic shoulder pain
- Being about to undergo open surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Regional Training Research Hospital
Erzurum, Yakutiye, 25100
About this study
Official title: Comparison of the Effectiveness of Interscalene Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Patients Undergoing Arthroscopic Shoulder Surgery
This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and serratus posterior superior intercostal plane block (SPSIP) for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery. The primary outcome is total 24-hour opioid consumption. Secondary outcomes include pain scores, hemidiaphragmatic paresis incidence and severity, duration of analgesia, and changes in lung function. Participants are randomized into ISB or SPSIP groups; blocks are performed under ultrasound guidance. Postoperative pain is managed with patient controlled analgesia(PCA).
- Conditions
- Shoulder Pain
- Being tested
- Interscalene Brachial Plexus Block (ISB), Serratus Posterior Superior Intercostal Plane Block (SPSIP)
- Keywords
- Postoperative pain, Analgesia, Regional Anesthesia, Interscalene brachial plexus block, Serratus posterior superior plane block
- Medical subject headings
- Shoulder Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene Brachial Plexus Block (ISB)Procedure or surgery
Patients receive ultrasound-guided ISB before arthroscopic shoulder surgery. 15 ml of 0.25% bupivacaine is injected using a 22 Gauge 50 mm needle with posterior in-plane approach, targeting C5-C6 roots.
Serratus Posterior Superior Intercostal Plane Block (SPSIP)Procedure or surgery
Patients receive ultrasound-guided SPSIP interfascial block in sitting position before surgery. Using a 22 Gauge 10 mm needle, 30 ml of 0.25% bupivacaine is injected between serratus posterior muscle and second rib.
| Study group | Role | What they receive |
|---|---|---|
| Interscalene Brachial Plexus Block (ISB) | Experimental | Patients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine. Receives: Procedure: Interscalene Brachial Plexus Block (ISB) |
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Patients will receive SPSIP block under ultrasound guidance using 30 ml 0.25% bupivacaine Receives: Procedure: Serratus Posterior Superior Intercostal Plane Block (SPSIP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 24-Hour Postoperative Opioid Consumption
Total intravenous opioid consumption recorded for each patient during the first 24 hours after arthroscopic shoulder surgery, including any rescue analgesia administered.
Measured: 0-24 hours postoperatively
Secondary outcomes (4)
Incidence and Severity of Hemidiaphragmatic Paresis
Ipsilateral hemidiaphragmatic function evaluated by M-mode ultrasonography before block and 30 minutes after block completion. Paresis classified as none (<25% reduction), partial (25-75% reduction), or complete (>75% reduction or paradoxical movement).
Measured: Pre-block and 30 minutes post-block
Duration of Analgesia
0-24 hours post-block
Measured: Time interval from block completion to initiation of IV PCA fentanyl in each patient
Pulmonary Function Changes (FEV1)
Pulmonary function measured with bedside spirometry pre-block and 30 minutes post-block. Forced expiratory volume in 1 second (FEV1) recorded; each measurement performed three times and mean value used.
Measured: Pre-block and 30 minutes post-block
Pulmonary Function Changes (FVC)
Pulmonary function measured with bedside spirometry pre-block and 30 minutes post-block. Forced vital capacity (FVC) recorded; each measurement performed three times and mean value used.
Measured: Pre-block and 30 minutes post-block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Dec 2024
- Primary completion1 Dec 2025
- Study completion15 Dec 2025
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 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Regional Training & Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Omer Doymus, Erzurum Regional Training & Research Hospital
- Investigators
- Ömer Doymus, MD, Principal investigator, Erzurum Regional Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311096
- Sponsor's protocol ID
- SBUERZURUMSHOULDER
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumari P, Kumar A, Aliyar R, Sinha L. Continuous serratus posterior superior intercostal plane block for postoperative analgesia in thoracotomy. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101570. doi: 10.1016/j.accpm.2025.101570. Epub 2025 Jun 14. No abstract available.
PubMed 40523524Dogan G, Kucuk O, Kayir S, Dal GC, Ciftci B, Zengin M, Alagoz A. Serratus posterior superior intercostal plane block versus thoracic paravertebral block for pain management after video-assisted thoracoscopic surgery: a randomized prospective study. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844647. doi: 10.1016/j.bjane.2025.844647. Epub 2025 Jun 3.
PubMed 40473018Ozen V, Turan EI, Alver S, Ciftci B, Cakir I, Sahin AS. Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in a Pediatric Patient Undergoing Lobectomy: A Case Report. A A Pract. 2025 May 27;19(5):e01988. doi: 10.1213/XAA.0000000000001988. eCollection 2025 May 1.
PubMed 40421887
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Interscalene Nerve Block and Serratus Posterior Superior Intercostal Plane Block in Patients Undergoing Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT07311096
- Acronym / sponsor ID
- SBUERZURUMSHOULDER
- Conditions
- Shoulder Pain
- Keywords
- Postoperative pain, Analgesia, Regional Anesthesia, Interscalene brachial plexus block, Serratus posterior superior plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Erzurum Regional Training & Research HospitalOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 30 Dec 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.
This randomized controlled trial aims to compare the effectiveness of interscalene (ISB) and serratus posterior superior intercostal plane block (SPSIP) for postoperative analgesia in patients undergoing elective arthroscopic shoulder surgery. The primary outcome is total 24-hour opioid consumption. Secondary outcomes include pain scores, hemidiaphragmatic paresis incidence and severity, duration of analgesia, and changes in lung function. Participants are randomized into ISB or SPSIP groups; blocks are performed under ultrasound guidance. Postoperative pain is managed with patient controlled analgesia(PCA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interscalene Brachial Plexus Block (ISB) | Experimental | Procedure: Interscalene Brachial Plexus Block (ISB)Patients will receive ISB under ultrasound guidance prior to arthroscopic shoulder surgery using 15 ml 0.25% bupivacaine. |
| Serratus Posterior Superior Intercostal Plane Block | Experimental | Procedure: Serratus Posterior Superior Intercostal Plane Block (SPSIP)Patients will receive SPSIP block under ultrasound guidance using 30 ml 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Agreeing to participate in the study
- The American Society of Anesthesiologists I-III
- Scheduled for elective unilateral arthroscopic shoulder surgery
Key exclusion criteria (8 listed)
- Refusal to participate in the study
- Allergy to the medications to be used
- History of serious heart, kidney or liver disease
- Neurological deficits or neuropathy
- History of anticoagulant use
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 |
|---|---|---|
| Interscalene Brachial Plexus Block (ISB)Patients receive ultrasound-guided ISB before arthroscopic shoulder surgery. 15 ml of 0.25% bupivacaine is injected using a 22 Gauge 50 mm needle with posterior in-plane approach, targeting C5-C6 roots. | Procedure or surgery | Interscalene Brachial Plexus Block (ISB) |
| Serratus Posterior Superior Intercostal Plane Block (SPSIP)Patients receive ultrasound-guided SPSIP interfascial block in sitting position before surgery. Using a 22 Gauge 10 mm needle, 30 ml of 0.25% bupivacaine is injected between serratus posterior muscle and second rib. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block |
Primary outcome
Total 24-Hour Postoperative Opioid Consumption
Time frame: 0-24 hours postoperatively
Total intravenous opioid consumption recorded for each patient during the first 24 hours after arthroscopic shoulder surgery, including any rescue analgesia administered.
4 secondary outcomes
Incidence and Severity of Hemidiaphragmatic Paresis
Time frame: Pre-block and 30 minutes post-block
Duration of Analgesia
Time frame: Time interval from block completion to initiation of IV PCA fentanyl in each patient
Pulmonary Function Changes (FEV1)
Time frame: Pre-block and 30 minutes post-block
Pulmonary Function Changes (FVC)
Time frame: Pre-block and 30 minutes post-block
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 30 Dec 2025.
- Background: PubMed 40523524Kumari P, Kumar A, Aliyar R, Sinha L. Continuous serratus posterior superior intercostal plane block for postoperative analgesia in thoracotomy. Anaesth Crit Care Pain Med. 2025 Sep;44(5):101570. doi: 10.1016/j.accpm.2025.101570. Epub 2025 Jun 14. No abstract available.
- Background: PubMed 40473018Dogan G, Kucuk O, Kayir S, Dal GC, Ciftci B, Zengin M, Alagoz A. Serratus posterior superior intercostal plane block versus thoracic paravertebral block for pain management after video-assisted thoracoscopic surgery: a randomized prospective study. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844647. doi: 10.1016/j.bjane.2025.844647. Epub 2025 Jun 3.
- Background: PubMed 40421887Ozen V, Turan EI, Alver S, Ciftci B, Cakir I, Sahin AS. Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in a Pediatric Patient Undergoing Lobectomy: A Case Report. A A Pract. 2025 May 27;19(5):e01988. doi: 10.1213/XAA.0000000000001988. eCollection 2025 May 1.
- 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.
Ömer Doymus, MD principal investigator
Erzurum Regional Training & Research 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 Interscalene Brachial Plexus Block (ISB) and Serratus Posterior Superior Intercostal Plane Block (SPSIP) in people with Shoulder Pain, run by Erzurum Regional Training & Research 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 8 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 30 Dec 2025. 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?
Total 24-Hour Postoperative Opioid Consumption (time frame: 0-24 hours postoperatively). 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 NCT07311096, 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 30 Dec 2025.