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COMPLETED
NCT03998813
NA

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

Sponsor: Centre Hospitalier Departemental Vendee

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

287

Start Date

2020-09-02

Completion Date

2024-04-08

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

Ropivacaine

Locoregional analgesia by femoral triangle catheterization

DRUG

Ropivacaine

Tissue infiltration

Locations (5)

Clinique Victor PAUCHET

Amiens, France

Centre Hospitalier de Béthune Beuvry

Béthune, France

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Hôpital des Diaconesses Croix Saint Simon

Paris, France

Hôpital Privé Sévigné

Rennes, France