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NCT Number: NCT06855381

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Anesthesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico

Foggia, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the ISBC group, SonoPlex needle and E-catheter

Procedure

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

Procedure

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

Primary outcomes

  1. Pain severity

    Time frame: 24 hour, 48 hour, 72 hour, 7 day

    Tha pain severity will be evaluated by NRS scale

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

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

Acronym: ISB

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Mar 3, 2025
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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