OsteoarthritisPhase 4LIANCT02365181
A Trial Between the Intra-articular Local Anesthetic Infiltration With Catheter and Interscalene Block With Catheter in Postoperative Analgesia After Shoulder Prosthesis
A Phase 4 study testing intra-articular local anesthetic infiltration, inter-scalene block and Ropivacaine 2 % in people with Osteoarthritis, run by Hospital Ambroise Paré Paris at 5 sites in France.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- intra-articular local anesthetic infiltration, inter-scalene block and Ropivacaine 2 %
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 5 sitesFrance
- Study dates
- Sep 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Shoulder arthroplasty
- Osteoarthritis
- Consent
Who cannot join
- Previous surgery in the same shoulder
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Polyclinique du Plateau
Bezons, 95870
Hospital Ambroise Paré Paris
Boulogne-Billancourt, 92000
Clinique Claude Bernard
Ermont, 95120
Clinique Jules Verne
Nantes, 44300
Institut Mutualiste Montsouris
Paris, 75014
About this study
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
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.
- Conditions
- Osteoarthritis
- Being tested
- intra-articular local anesthetic infiltration, inter-scalene block, Ropivacaine 2 %
- Keywords
- Shoulder arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular local anesthetic infiltrationProcedure or surgery
intra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter
inter-scalene blockProcedure or surgery
inter-scalene block with 20 ml of Ropivacaine 2 % and catheter
Ropivacaine 2 %Drug
20 ml of Ropivacaine 2 %
| Study group | Role | What they receive |
|---|---|---|
| IAL | Experimental | intra-articular local anesthetic infiltration with catheter Receives: Procedure: intra-articular local anesthetic infiltration; Drug: Ropivacaine 2 % |
| ISB | Active comparator | interscalene block with catheter Receives: Procedure: inter-scalene block; Drug: Ropivacaine 2 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean postoperative pain
Measured: during the 48 first hours
Secondary outcomes (1)
Complications dues to anesthesia procedure
Measured: At 12 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Ambroise Paré Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365181
- Sponsor's protocol ID
- APR092014
- Acronym
- LIA
- Status last verified
- Aug 2016
- First submitted
- 6 Feb 2015
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02365181
- Acronym / sponsor ID
- LIA / APR092014
- Conditions
- Osteoarthritis
- Keywords
- Shoulder arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospital Ambroise Paré ParisUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IAL | Experimental | Procedure: intra-articular local anesthetic infiltration, Drug: Ropivacaine 2 %intra-articular local anesthetic infiltration with catheter |
| ISB | Active comparator | Procedure: inter-scalene block, Drug: Ropivacaine 2 %interscalene block with catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Shoulder arthroplasty
- Osteoarthritis
- Consent
Key exclusion criteria (1 listed)
- Previous surgery in the same shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-articular local anesthetic infiltrationintra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter | Procedure or surgery | IAL |
| inter-scalene blockinter-scalene block with 20 ml of Ropivacaine 2 % and catheter | Procedure or surgery | ISB |
| Ropivacaine 2 %20 ml of Ropivacaine 2 % | Drug | IAL, ISB |
Primary outcome
Mean postoperative pain
Time frame: during the 48 first hours
1 secondary outcome
Complications dues to anesthesia procedure
Time frame: At 12 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intra-articular local anesthetic infiltration, inter-scalene block and Ropivacaine 2 % in people with Osteoarthritis, run by Hospital Ambroise Paré Paris at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean postoperative pain (time frame: during the 48 first hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.