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

Osteoarthritis Clinical Trial

— LIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365181
• Other study ID #: APR092014
• Status: Completed
• Phase: Phase 4
• First received: February 6, 2015
• Last updated: August 2, 2016
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Hospital Ambroise Paré Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Shoulder arthroplasty

• Osteoarthritis

• Consent

Exclusion Criteria:

• Previous surgery in the same shoulder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Procedure:
• intra-articular local anesthetic infiltration
intra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter
• inter-scalene block
inter-scalene block with 20 ml of Ropivacaine 2 % and catheter

Drug:
• Ropivacaine 2 %
20 ml of Ropivacaine 2 %

Locations

Country	Name	City	State
France	Polyclinique du Plateau	Bezons
France	Hospital Ambroise Paré Paris	Boulogne-Billancourt
France	Clinique Claude Bernard	Ermont
France	Clinique Jules Verne	Nantes
France	Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean postoperative pain		during the 48 first hours	No
Secondary	Complications dues to anesthesia procedure		At 12 hours after surgery	Yes