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

August 2, 2016 updated by: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bezons, France, 95870
        • Polyclinique du Plateau
      • Boulogne-Billancourt, France, 92000
        • Hospital Ambroise Paré Paris
      • Ermont, France, 95120
        • Clinique Claude Bernard
      • Nantes, France, 44300
        • Clinique Jules Verne
      • Paris, France, 75014
        • Institut Mutualiste Montsouris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shoulder arthroplasty
  • Osteoarthritis
  • Consent

Exclusion Criteria:

  • Previous surgery in the same shoulder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IAL
intra-articular local anesthetic infiltration with catheter
Procedure: intra-articular local anesthetic infiltration
intra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter
Drug: Ropivacaine 2 %
20 ml of Ropivacaine 2 %
Active Comparator: ISB
interscalene block with catheter
Drug: Ropivacaine 2 %
20 ml of Ropivacaine 2 %
Procedure: inter-scalene block
inter-scalene block with 20 ml of Ropivacaine 2 % and catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean postoperative pain
Time Frame: during the 48 first hours
during the 48 first hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications dues to anesthesia procedure
Time Frame: At 12 hours after surgery
At 12 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ambroise Paré Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR092014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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