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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06855381
Acronym
ISB
Enrollment
80
Registered
2025-03-03
Start date
2022-02-01
Completion date
2025-02-28
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

interscalene block, pain management, regional anesthesia, shoulder arthroscopy

Brief 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.

Interventions

PROCEDUREthe 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.

PROCEDUREsingle 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

Sponsors

University of Foggia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain severity24 hour, 48 hour, 72 hour, 7 dayTha pain severity will be evaluated by NRS scale

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026