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Active Not RecruitingNCT06855381

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

Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Injection Versus Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair-a Prospective Randomized Unblinded Trial

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
University of Foggia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Blocks will be performed under ultrasound guidance with 15 - 20 mL of 0.75 % ropivacaine.

Conditions

Interventions

TypeNameDescription
PROCEDUREthe ISBC group, SonoPlex needle and E-catheterin 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.
PROCEDUREsingle bolus injectionAn 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

Timeline

Start date
2022-02-01
Primary completion
2024-02-28
Completion
2025-02-28
First posted
2025-03-03
Last updated
2025-03-03

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06855381. Inclusion in this directory is not an endorsement.