NCT07874672

Brief 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. 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).

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

October 5, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

October 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

October 5, 2026

Last Update Submit

October 9, 2026

Conditions

Keywords

SPSIP blockshoulder arthroscopy

Outcome Measures

Primary Outcomes (1)

  • 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

    30 min after SPSIP block

Secondary Outcomes (3)

  • Motor sparing (shoulder abduction)

    30 minutes post-SPSIP block

  • Motor sparing (external rotation)

    30 minutes post-SPSIP block

  • Diaphragmatic Excursion

    30 minutes post-SPSIP block

Study Arms (1)

Peolple undergoing shoulder arthroscopy surgeries

Procedure: SPSIPB block

Interventions

SPSIPB blockPROCEDURE

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
Peolple undergoing shoulder arthroscopy surgeries

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing shoulder arthroscopy in the operating rooms of Piove di Sacco Hospital (Italy).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD - Resident in Anesthesiology

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 15, 2026

Study Start

October 6, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

October 15, 2026

Record last verified: 2026-10