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

• ClinicalTrials.gov Identifier: NCT02365181
• Recruitment Status: Completed
• First Posted: February 18, 2015
• Last Update Posted: August 4, 2016
• Sponsor: Hospital Ambroise Paré Paris
• Information provided by (Responsible Party): Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Procedure: intra-articular local anesthetic infiltration; Procedure: inter-scalene block; Drug: Ropivacaine 2 %	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: September 2014
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

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	Procedure: inter-scalene block; inter-scalene block with 20 ml of Ropivacaine 2 % and catheter; Drug: Ropivacaine 2 %; 20 ml of Ropivacaine 2 %

Outcome Measures

Primary Outcome Measures :

1. Mean postoperative pain [ Time Frame: during the 48 first hours ]

Secondary Outcome Measures :

1. Complications dues to anesthesia procedure [ Time Frame: At 12 hours after surgery ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Shoulder arthroplasty
• Osteoarthritis
• Consent

Exclusion Criteria:

• Previous surgery in the same shoulder

Contacts and Locations

Locations

France

Polyclinique du Plateau

Bezons, France, 95870

Hospital Ambroise Paré Paris

Boulogne-Billancourt, France, 92000

Clinique Claude Bernard

Ermont, France, 95120

Clinique Jules Verne

Nantes, France, 44300

Institut Mutualiste Montsouris

Paris, France, 75014

Sponsors and Collaborators

Hospital Ambroise Paré Paris

More Information

• Responsible Party: Shahnaz Klouche, MD, Physician responsible of clinical research, Hospital Ambroise Paré Paris
• ClinicalTrials.gov Identifier: NCT02365181
• Other Study ID Numbers: APR092014
• First Posted: February 18, 2015
• Last Update Posted: August 4, 2016
• Last Verified: August 2016

Keywords provided by Shahnaz Klouche, MD, Hospital Ambroise Paré Paris:

Shoulder arthroplasty

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents