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 (TKAFTER)

  • STATUS
    Recruiting
  • End date
    Mar 25, 2024
  • participants needed
    420
  • sponsor
    Centre Hospitalier Departemental Vendee
Updated on 25 October 2022
analgesics
analgesia
morphine
osteoarthritis
chronic pain
total knee replacement
NSAID

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%).

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.

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.

Details
Condition Knee Pain Chronic
Treatment ropivacaine
Clinical Study IdentifierNCT03998813
SponsorCentre Hospitalier Departemental Vendee
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note