An observational study in Shoulder Arthroscopic Surgeries, sponsored by ULSS6 - Ospedale di Piove di Sacco. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by ULSS6 - Ospedale di Piove di Sacco · Observational
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).
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.
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.
This is the only study on the registry with ULSS6 - Ospedale di Piove di Sacco as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adult patients undergoing shoulder arthroscopy in the operating rooms of Piove di Sacco Hospital (Italy).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: SPSIPB block
It will be performed the serratus posterior superior intercostal plane block (SPSIP block) before shoulder arthroscopy surgery.
Also known as: serratus posterior superior intercostal plane block
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
Time frame: 30 min after SPSIP block
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
Time frame: 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.
Time frame: 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
Time frame: 30 minutes post-SPSIP block
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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