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Clinical Trials in Italy / NCT06855381
Active, not recruiting Not applicable

Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus vs Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair

NCT06855381 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Foggia
Phase
Not applicable
Started
2022-02-01
Last updated
2025-03-03

Condition(s) studied

Anesthesia

Investigational drug(s) / intervention(s)

the ISBC group, SonoPlex needle and E-cathetersingle bolus injection

the ISBC group, SonoPlex needle and E-catheter: in the ISBC group, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used. The E-catheter will be inserted into the indwelling cannula.

single bolus injection: An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this group a 22G 50 mm needle will be used

Study summary

Shoulder arthroscopy is a minimally invasive procedure frequently used for rotator cuff repair. Patients may experience severe postoperative (PO) pain, that can last for a month and can influence successful rehabilitation. Our study aimes to evaluate the effectiveness of interscalene brachial plexus single-shot (ISBSS) versus continuous interscalene brachial plexus block (ISBC) in controlling perioperative pain and avoiding PO pain chronicization. This prospective randomized unblinded trial hypothesizes that the PO perineuronal infusion using a continuous ambulatory delivery device pump gives better pain control and outcomes than ISBSS during the long-term follow-up period.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * American Society of Anesthesia (ASA) physical status of 1 to 2, * Body Mass Index (BMI) of less than 30 kg/m², * paitents undergoing shoulder arthroscopy for small to medium rotator cuff tears. Exclusion Criteria: * skin infection on the puncture site, * coagulopathy * brachial plexus neuropathy * alcohol or drug abuse * diabetes * severe lung disease * history of allergy to one or more study drugs.

Primary outcome measure(s)

  • Pain severity — 24 hour, 48 hour, 72 hour, 7 day
    Tha pain severity will be evaluated by NRS scale

Trial sites (1)

FacilityCityRegionStatus
Policlinico Foggia Italy

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Other trials for the same condition

A Study to Compare the Long-term Outcomes After Two Different Anaesthetics Active, not recruiting
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Anesthesia and Critical Care Registry Recruiting
Comparison of Three Pre-oxygenation Strategies Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06855381 on ClinicalTrials.gov ↗ ← All trials in Italy