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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02365181
Acronym
LIA
Enrollment
98
Registered
2015-02-18
Start date
2014-09-30
Completion date
2016-06-30
Last updated
2016-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Shoulder arthroplasty

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.

Interventions

PROCEDUREintra-articular local anesthetic infiltration

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

PROCEDUREinter-scalene block

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

DRUGRopivacaine 2 %

20 ml of Ropivacaine 2 %

Sponsors

Hospital Ambroise Paré Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Shoulder arthroplasty * Osteoarthritis * Consent

Exclusion criteria

* Previous surgery in the same shoulder

Design outcomes

Primary

MeasureTime frame
Mean postoperative painduring the 48 first hours

Secondary

MeasureTime frame
Complications dues to anesthesia procedureAt 12 hours after surgery

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026