Shoulder Arthroscopic SurgeriesNCT07874672
SPSIP Block in Shoulder Artroscopy
An observational study of Shoulder Arthroscopic Surgeries, run by ULSS6 - Ospedale di Piove di Sacco at 1 site in Italy.
Trial summary
The SPSIP block study aims to systematically describe the distribution of sensory blockade across the region involved in shoulder arthroscopy, as well as the degree of motor sparing of the ipsilateral upper limb and hemidiaphragm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthroscopic Surgeries
- What is being tested?
- SPSIPB block
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2026to Mar 2027
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing shoulder arthroscopy in the operating rooms of Piove di Sacco Hospital (Italy).
Who may be able to join
- Patients scheduled for shoulder arthroscopy receiving an SPSIP block as the analgesic technique.
- Age ≥ 18 years.
- Patients able to provide informed consent to study participation and to the processing of personal data.
Who cannot join
- Refusal to provide consent to study participation.
- Pre-existing central or peripheral sensory neuropathy.
- Estimated time between block performance and entry into the operating room of less than 30 minutes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale di Piove di Sacco
Piove di Sacco, Padova, 35028
Alessio Rotondi, MD, +39 3899224280, alessio.rotondi@aulss6.veneto.it
About this study
Official title: Clinical Effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) in Shoulder Arthroscopy: an Exploratory Prospective Observational Study
The SPSIP block study aims to systematically describe the distribution of sensory blockade across the region involved in shoulder arthroscopy, as well as the degree of motor sparing of the ipsilateral upper limb and hemidiaphragm. We will assess the sensory response with a cold cotton swab that will be used to compare the sensation of the operated shoulder with that of the opposite (contralateral) shoulder. The patient will be asked whether the feeling of cold is unchanged or altered along the shoulder. This will be tested over an area extending 15 cm anteriorly, laterally and posteriorly. This test will take place 30 min after the SPSIP block. We will also assess the range of motion of the limb undergoing surgery before and after 30 min the anaesthetic procedure. The patient will be asked to perform shoulder abduction and external rotation movements, which the anesthesiologist will explain. We will also measure the diaphragmatic excursion using ultrasound. This procedure will also be performed before and 30 min after the nerve block: the patient will be asked to take deep breaths while the anesthesiologist performs the ultrasound scan.
The study will include adult patients (≥ 18 years) scheduled for shoulder arthroscopy who receive an SPSIP block as the analgesic technique and are able to provide informed consent to study participation and to the processing of personal data will be enrolled.This is a single-centre study conducted exclusively at Piove di Sacco Hospital (Italy).
Read the detailed description
Background The interscalene block, the analgesic gold standard for shoulder arthroscopy, causes hemidiaphragmatic paresis in nearly all patients and significant upper-limb motor block. The serratus posterior superior intercostal plane (SPSIP) block targets the upper thoracic spinal nerves (T2-T5) deep to the serratus posterior superior muscle, far from the brachial plexus and phrenic nerve, and may therefore provide analgesia with less motor and diaphragmatic involvement. Its sensory distribution and diaphragmatic effects have not yet been systematically described.
Design Prospective, single-center, exploratory observational study at Piove di Sacco Hospital (ULSS6 Euganea, Italy). Only patients in whom the attending anesthesiologist has already chosen the SPSIP block are enrolled; all assessments are part of routine care and the study does not modify anesthetic management.
Procedures At the time of the block, age, sex, weight, height, and type, volume and dose of local anesthetic are recorded.
- Sensory block (30 min after the block): a swab cooled with ice spray is applied from the acromion in 1-cm steps along lateral, anterior and posterior lines (15 cm each). Each point is scored 1 (absent or reduced cold sensation vs. the contralateral side) or 0 (preserved), producing a sensory map.
- Upper-limb motor function (before and 30 min after the block): shoulder abduction (axillary nerve) and external rotation (suprascapular nerve), elbow at 90°, measured in degrees with a goniometer.
- Diaphragmatic function (before and 30 min after the block): M-mode ultrasound excursion during deep inspiration. Reduction from baseline is graded 0 (< 25%), 1 (25-75%, partial paresis) or 2 (> 75% or paradoxical movement, complete paralysis).
Surgery is then performed under general anesthesia; no intraoperative or postoperative data are collected.
Statistical analysis A pragmatic sample of 20 patients was chosen, as no formal sample size calculation was possible. Data will be analyzed descriptively; pre- and post-block diaphragmatic excursion will be compared with the paired t-test or Wilcoxon signed-rank test. Results will inform a future confirmatory study.
- Conditions
- Shoulder Arthroscopic Surgeries
- Being tested
- SPSIPB block
- Keywords
- SPSIP block, shoulder arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPSIPB blockProcedure or surgery
Also called serratus posterior superior intercostal plane block
It will be performed the serratus posterior superior intercostal plane block (SPSIP block) before shoulder arthroscopy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Peolple undergoing shoulder arthroscopy surgeries | Not described Receives: Procedure: SPSIPB block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory blockade at 30 minutes
A cold cotton ball will be applied in the sensory territory of the shoulder in order to describe the loss of sensation by the SPSIP block across in this region
Measured: 30 min after SPSIP block
Secondary outcomes (3)
Motor sparing (shoulder abduction)
Motor sparing will also be quantified by assessing shoulder abduction (axillary nerve). The movement will be assessed in degrees using a goniometer
Measured: 30 minutes post-SPSIP block
Motor sparing (external rotation)
Motor sparing will also be quantified by assessing external rotation (suprascapular nerve). It will be assessed in degrees using a goniometer.
Measured: 30 minutes post-SPSIP block
Diaphragmatic Excursion
The diaphramg excursion during normal breath will be evalauted by using an ultrasound machine (M-Mode) and measured in millimiters
Measured: 30 minutes post-SPSIP block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start14 Oct 2026
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Arthroscopic SurgeriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ULSS6 - Ospedale di Piove di Sacco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dott. Alessio Rotondi, ULSS6 - Ospedale di Piove di Sacco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874672
- Sponsor's protocol ID
- 6603/U6/26
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIP Block) in Shoulder Arthroscopy: an Exploratory Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07874672
- Acronym / sponsor ID
- 6603/U6/26
- Conditions
- Shoulder Arthroscopic Surgeries
- Keywords
- SPSIP block, shoulder arthroscopy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ULSS6 - Ospedale di Piove di SaccoUniversity, hospital or other
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Oct 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.
The SPSIP block study aims to systematically describe the distribution of sensory blockade across the region involved in shoulder arthroscopy, as well as the degree of motor sparing of the ipsilateral upper limb and hemidiaphragm. We will assess the sensory response with a cold cotton swab that will be used to compare the sensation of the operated shoulder with that of the opposite (contralateral) shoulder. The patient will be asked whether the feeling of cold is unchanged or altered along the shoulder. This will be tested over an area extending 15 cm anteriorly, laterally and posteriorly. This test will take place 30 min after the SPSIP block. We will also assess the range of motion of the limb undergoing surgery before and after 30 min the anaesthetic procedure. The patient will be asked to perform shoulder abduction and external rotation movements, which the anesthesiologist will explain. We will also measure the diaphragmatic excursion using ultrasound. This procedure will also be performed before and 30 min after the nerve block: the patient will be asked to take deep breaths while the anesthesiologist performs the ultrasound scan.
The study will include adult patients (≥ 18 years) scheduled for shoulder arthroscopy who receive an SPSIP block as the analgesic technique and are able to provide informed consent to study participation and to the processing of personal data will be enrolled.This is a single-centre study conducted exclusively at Piove di Sacco Hospital (Italy).
Detailed description
Background The interscalene block, the analgesic gold standard for shoulder arthroscopy, causes hemidiaphragmatic paresis in nearly all patients and significant upper-limb motor block. The serratus posterior superior intercostal plane (SPSIP) block targets the upper thoracic spinal nerves (T2-T5) deep to the serratus posterior superior muscle, far from the brachial plexus and phrenic nerve, and may therefore provide analgesia with less motor and diaphragmatic involvement. Its sensory distribution and diaphragmatic effects have not yet been systematically described.
Design Prospective, single-center, exploratory observational study at Piove di Sacco Hospital (ULSS6 Euganea, Italy). Only patients in whom the attending anesthesiologist has already chosen the SPSIP block are enrolled; all assessments are part of routine care and the study does not modify anesthetic management.
Procedures At the time of the block, age, sex, weight, height, and type, volume and dose of local anesthetic are recorded.
- Sensory block (30 min after the block): a swab cooled with ice spray is applied from the acromion in 1-cm steps along lateral, anterior and posterior lines (15 cm each). Each point is scored 1 (absent or reduced cold sensation vs. the contralateral side) or 0 (preserved), producing a sensory map.
- Upper-limb motor function (before and 30 min after the block): shoulder abduction (axillary nerve) and external rotation (suprascapular nerve), elbow at 90°, measured in degrees with a goniometer.
- Diaphragmatic function (before and 30 min after the block): M-mode ultrasound excursion during deep inspiration. Reduction from baseline is graded 0 (< 25%), 1 (25-75%, partial paresis) or 2 (> 75% or paradoxical movement, complete paralysis).
Surgery is then performed under general anesthesia; no intraoperative or postoperative data are collected.
Statistical analysis A pragmatic sample of 20 patients was chosen, as no formal sample size calculation was possible. Data will be analyzed descriptively; pre- and post-block diaphragmatic excursion will be compared with the paired t-test or Wilcoxon signed-rank test. Results will inform a future confirmatory study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peolple undergoing shoulder arthroscopy surgeries | – | Procedure: SPSIPB block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing shoulder arthroscopy in the operating rooms of Piove di Sacco Hospital (Italy).
Key inclusion criteria (3 listed)
- Patients scheduled for shoulder arthroscopy receiving an SPSIP block as the analgesic technique.
- Age ≥ 18 years.
- Patients able to provide informed consent to study participation and to the processing of personal data.
Key exclusion criteria (3 listed)
- Refusal to provide consent to study participation.
- Pre-existing central or peripheral sensory neuropathy.
- Estimated time between block performance and entry into the operating room of less than 30 minutes.
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 blockAlso: serratus posterior superior intercostal plane blockIt will be performed the serratus posterior superior intercostal plane block (SPSIP block) before shoulder arthroscopy surgery. | Procedure or surgery | Peolple undergoing shoulder arthroscopy surgeries |
Primary outcome
Sensory blockade at 30 minutes
Time frame: 30 min after SPSIP block
A cold cotton ball will be applied in the sensory territory of the shoulder in order to describe the loss of sensation by the SPSIP block across in this region
3 secondary outcomes
Motor sparing (shoulder abduction)
Time frame: 30 minutes post-SPSIP block
Motor sparing (external rotation)
Time frame: 30 minutes post-SPSIP block
Diaphragmatic Excursion
Time frame: 30 minutes post-SPSIP block
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 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthroscopic Surgeries, run by ULSS6 - Ospedale di Piove di Sacco at 1 site in Italy.
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 3 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 21 Oct 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 Italy. 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 Alessio Rotondi, Doctor (0039 3899224280, alessio.rotondi@aulss6.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory blockade at 30 minutes (time frame: 30 min after SPSIP block). 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 21 Oct 2026.