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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: intra-articular local anesthetic infiltration; Procedure: inter-scalene block; Drug: Ropivacaine 2 %

• Registration Number: NCT02365181
• Lead Sponsor: Hospital Ambroise Paré Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-17
• Study First Posted: 2015-02-18
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Shoulder arthroplasty
• Osteoarthritis
• Consent

Exclusion Criteria

• Previous surgery in the same shoulder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IAL	Ropivacaine 2 %	intra-articular local anesthetic infiltration with catheter
IAL	intra-articular local anesthetic infiltration	intra-articular local anesthetic infiltration with catheter
ISB	inter-scalene block	interscalene block with catheter
ISB	Ropivacaine 2 %	interscalene block with catheter

Primary Outcome Measures

Name	Time	Method
Mean postoperative pain	during the 48 first hours

Secondary Outcome Measures

Name	Time	Method
Complications dues to anesthesia procedure	At 12 hours after surgery

Trial Locations

Locations (5)

Polyclinique du Plateau; 🇫🇷 Bezons, France

Clinique Jules Verne; 🇫🇷 Nantes, France

Hospital Ambroise Paré Paris; 🇫🇷 Boulogne-Billancourt, France

Clinique Claude Bernard; 🇫🇷 Ermont, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France