NCT02365181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 4, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

February 6, 2015

Last Update Submit

August 2, 2016

Conditions

Osteoarthritis

Keywords

Shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Mean postoperative pain

    during the 48 first hours

Secondary Outcomes (1)

  • Complications dues to anesthesia procedure

    At 12 hours after surgery

Study Arms (2)

IAL

EXPERIMENTAL

intra-articular local anesthetic infiltration with catheter

Procedure: intra-articular local anesthetic infiltrationDrug: Ropivacaine 2 %

ISB

ACTIVE COMPARATOR

interscalene block with catheter

Procedure: inter-scalene blockDrug: Ropivacaine 2 %

Interventions

intra-articular local anesthetic infiltrationPROCEDURE

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

IAL
inter-scalene blockPROCEDURE

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

ISB
Ropivacaine 2 %DRUG

20 ml of Ropivacaine 2 %

IALISB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Shoulder arthroplasty
  • Osteoarthritis
  • Consent

You may not qualify if:

  • Previous surgery in the same shoulder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Polyclinique du Plateau

Bezons, 95870, France

Location

Hospital Ambroise Paré Paris

Boulogne-Billancourt, 92000, France

Location

Clinique Claude Bernard

Ermont, 95120, France

Location

Clinique Jules Verne

Nantes, 44300, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician responsible of clinical research

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 18, 2015

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 4, 2016

Record last verified: 2016-08

Locations

FR(5)