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Clinical Trials/NCT06855381
NCT06855381
Active, not recruiting
Not Applicable

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

University of Foggia1 site in 1 country80 target enrollmentStarted: February 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
University of Foggia
Enrollment
80
Locations
1
Primary Endpoint
Pain severity

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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
  • severe lung disease
  • history of allergy to one or more study drugs.

Outcomes

Primary Outcomes

Pain severity

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

Tha pain severity will be evaluated by NRS scale

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Foggia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cotoia Antonella

Doctor

University of Foggia

Study Sites (1)

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