Knee Pain ChronicTKAFTERNCT03998813
Chronic Pain and Functional Prognosis After Total Knee Replacement: Continuous Locoregional Analgesia by Catheter to the Femoral Triangle Versus Tissue Infiltration as Part of an Improved Rehabilitation After Surgery Approach
A study testing Ropivacaine in people with Knee Pain Chronic, run by Centre Hospitalier Departemental Vendee at 5 sites in France.
Trial summary
The prevalence of Chronic Post-Surgical Pain (CPSP) after knee replacement, defined as pain greater than or equal to 4/10 on the visual analogue scale after the third postoperative month, is recognised as high, with an average of 20% (extremes of 7 to 45%). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 5 sitesFrance
- Study dates
- 2 Sep 2020to 8 Apr 2024
- Phase
- Interventional
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient;
- Placement of unilateral tricompartmental knee prosthesis for gonarthrosis;
- ASA score between I and III ;
- Nonseptic scheduled surgery;
- Knee replacement scheduled on one of the first 3 days of the week (Monday to Wednesday included) in order to benefit from a homogeneous postoperative physical therapy;
- Able to understand the protocol;
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- Having agreed to participate in the study and having given express oral consent;
- Affiliated with a social security system;
- Possibility of being followed as part of the protocol.
Who cannot join
- Age >= 86 years old;
- BMI > 35 ;
- Revision of knee replacement;
- Symptomatic contralateral osteoarthritis;
- Anterior of surgery on the operated knee (excluding arthroscopy and meniscectomy);
- Vascular surgery on the femoral vessels on the operated side;
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- Concept of diffuse polyalgia syndrome (fibromyalgia);
- Documented neuropathy of the lower limb;
- Localized infection at the catheter puncture site (femoral triangle);
- Known allergy to Ropivacaine;
- Renal insufficiency (Clearance - CKD-EPI formula - creatinine <30 ml/min) and/or severe hepatic insufficiency (prothrombin blood level <50%) ;
- Inflammatory rheumatic disease (rheumatoid arthritis, ankylosing spondylitis...) ;
- Patients on immunosuppressive or systemically administered corticosteroid therapy;
- Daily use of level II or III analgesics for more than one month pre-operatively;
- Known intolerance to tier III analgesics;
- Allergy or contraindications to standard treatments administered per and postoperatively (paracetamol, NSAIDs);
- Patient undergoing knee surgery in the year prior to inclusion and participating in the study;
- Patients who do not cooperate or do not understand French, difficulties in understanding and evaluating the pain score, preoperative cognitive dysfunction making the interview unreliable;
- Patient under guardianship, curators, deprivation of liberty;
- Patient already engaged in another interventional clinical study (category 1);
- Pregnant or breastfeeding women, or women in a position to procreate who refuse an effective means of contraception;
- Refusal to participate;
- Inability to understand the protocol and its requirements, and/or to give express oral consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique Victor PAUCHET
Amiens
Centre Hospitalier de Béthune Beuvry
Béthune
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85925
Hôpital des Diaconesses Croix Saint Simon
Paris
Hôpital Privé Sévigné
Rennes
About this study
The prevalence of Chronic Post-Surgical Pain (CPSP) after knee replacement, defined as pain greater than or equal to 4/10 on the visual analogue scale after the third postoperative month, is recognised as high, with an average of 20% (extremes of 7 to 45%).
These CPSP, when present, cause poor long-term joint functional prognosis and impaired quality of life for patients. Many predictive, pre-, per- and post-operative factors of these CPSP have been identified in recent years. The most common postoperative risk factor found in the literature is the intensity of early pain.
Read more
The treatment protocols for this early post-surgical pain are currently and mainly multimodal in nature, combining systemic analgesics (paracetamol, NSAIDs, morphine, gabapentins) and local anaesthetics, administered either in the form of peripheral nerve blocks (continuous or single injection) or in the form of tissue infiltration (TI) performed by the surgeon during the operation.
Very few of these techniques have been evaluated for their ability to reduce the incidence of CPSP. Drugs with antihyperalgesic properties such as ketamine or nefopam have been shown to be of no interest, except to reduce the proportion of pain of a neuropathic nature. Only the continuous femoral block has shown, to date, an interest in IT to reduce the incidence of these CPSP.
The main objective of this study is to show that a multimodal analgesia protocol based on continuous locoregional analgesia by femoral triangle catheterization could reduce the incidence of chronic post surgical pain compared to a protocol based on tissue infiltration.
- Conditions
- Knee Pain Chronic
- Being tested
- Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Locoregional analgesia by femoral triangle catheterization
RopivacaineDrug
Tissue infiltration
| Study group | Role | What they receive |
|---|---|---|
| Locoregional analgesia by femoral triangle catheterization | Experimental | Not described Receives: Drug: Ropivacaine |
| Tissue infiltration | Active comparator | Not described Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Pain Assessment Scale
Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable).
Measure is positive when score is >= 4
Measured: Three months from the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start2 Sep 2020
- Primary completion26 Jun 2023
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee Pain ChronicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme GUILLEY, Study director, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998813
- Sponsor's protocol ID
- CHD038-19
- Acronym
- TKAFTER
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2019
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No