A Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis

NCT ID: NCT02365181

Last Updated: 2016-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-06-30

Brief Summary

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The control of perioperative pain is necessary to avoid worst surgical suites after shoulder arthroplasty. Interscalene block (ISB) with or without catheter is the gold standard in postoperative analgesia after shoulder prosthesis but neurological or respiratory adverse events can occured . The intra-articular local (IAL) anesthetic infiltration with catheter is a simple procedure. Its efficacy was proved in knee and hip arthroplasty but not in shoulder arthroplasty. Our hypothesis was the IAL is as effective as ISB in early postoperative analgesia after shoulder arthroplasty.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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IAL

intra-articular local anesthetic infiltration with catheter

Group Type EXPERIMENTAL

intra-articular local anesthetic infiltration

Intervention Type PROCEDURE

intra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter

Ropivacaine 2 %

Intervention Type DRUG

20 ml of Ropivacaine 2 %

ISB

interscalene block with catheter

Group Type ACTIVE_COMPARATOR

inter-scalene block

Intervention Type PROCEDURE

inter-scalene block with 20 ml of Ropivacaine 2 % and catheter

Ropivacaine 2 %

Intervention Type DRUG

20 ml of Ropivacaine 2 %

Interventions

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intra-articular local anesthetic infiltration

intra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter

Intervention Type PROCEDURE

inter-scalene block

inter-scalene block with 20 ml of Ropivacaine 2 % and catheter

Intervention Type PROCEDURE

Ropivacaine 2 %

20 ml of Ropivacaine 2 %

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Shoulder arthroplasty
* Osteoarthritis
* Consent

Exclusion Criteria

* Previous surgery in the same shoulder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Ambroise Paré Paris

OTHER

Sponsor Role lead

Responsible Party

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Shahnaz Klouche, MD

Physician responsible of clinical research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Polyclinique du Plateau

Bezons, , France

Site Status

Hospital Ambroise Paré Paris

Boulogne-Billancourt, , France

Site Status

Clinique Claude Bernard

Ermont, , France

Site Status

Clinique Jules Verne

Nantes, , France

Site Status

Institut Mutualiste Montsouris

Paris, , France

Site Status

Countries

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France

Other Identifiers

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APR092014

Identifier Type: -

Identifier Source: org_study_id

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