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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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 groups in NCT07311096
Study groupRoleWhat they receive
Interscalene Brachial Plexus Block (ISB)ExperimentalPatients 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 BlockExperimentalPatients 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.

  1. 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)
  1. 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

  2. Duration of Analgesia

    0-24 hours post-block

    Measured: Time interval from block completion to initiation of IV PCA fentanyl in each patient

  3. 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

  4. 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.

  1. First posted30 Dec 2025
  2. Study start1 Dec 2024
  3. Primary completion1 Dec 2025
  4. Study completion15 Dec 2025

Resources

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)
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 40523524
  • Dogan 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 40473018
  • Ozen 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

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.

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