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

NCT03998813 | Completed Results

• 1 other identifier: CHD038-19
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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

  Three months from the intervention

Study Arms (2)

Locoregional analgesia by femoral triangle catheterization

EXPERIMENTAL

Drug: Ropivacaine

Tissue infiltration

ACTIVE COMPARATOR

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Locoregional analgesia by femoral triangle catheterization

Locoregional analgesia by femoral triangle catheterization

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (5)

Clinique Victor PAUCHET

Amiens, France

Location

Centre Hospitalier de Béthune Beuvry

Béthune, France

Location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85925, France

Location

Hôpital des Diaconesses Croix Saint Simon

Paris, France

Location

Hôpital Privé Sévigné

Rennes, France

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Jérôme GUILLEY
• Organization: CHD VENDEE

jerome.guilley@ght85.fr

02 51 44 65 72

Study Officials

• Jérôme GUILLEY

  CHD Vendée

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: September 2, 2020
• Primary Completion: June 26, 2023
• Study Completion: April 8, 2024
• Last Updated: June 12, 2026
• Results First Posted: June 12, 2026

Record last verified: 2026-06

Locations

FR (5)