Ultrasound-guided Interscalene Brachial Plexus Block: Single Bolus Vs Continuous Catheter Placement in Arthroscopic Rotator Cuff Repair (ISB)

University of Foggia

Status: Active, not recruiting

Conditions: Anesthesia

Treatments: Procedure: the ISBC group, SonoPlex needle and E-catheter; Procedure: single bolus injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06855381

unifg

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

effectiveness of interscalene brachial plexus single-shot

Active Comparator group

Description:

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

Treatment:

Procedure: single bolus injection

continuous interscalene brachial plexus block

Experimental group

Description:

An ultrasound-guided peripheral nerve block puncture will be performed from the lateral to the medial side of the neck. In this arm, a 22G 50 mm SonoPlex needle with an indwelling cannula will be used.

Treatment:

Procedure: the ISBC group, SonoPlex needle and E-catheter