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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)

Primary Purpose

Knee Pain Chronic

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ropivacaine
Ropivacaine
Sponsored by
Centre Hospitalier Departemental Vendee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Pain Chronic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinique Victor PAUCHET
  • Centre Hospitalier de Béthune Beuvry
  • Centre Hospitalier Départemental Vendée
  • Hôpital des Diaconesses Croix Saint Simon
  • Hôpital Privé Sévigné

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Locoregional analgesia by femoral triangle catheterization

Tissue infiltration

Arm Description

Outcomes

Primary Outcome Measures

A walking pain assessment scale greater than or equal to 4
Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable)

Secondary Outcome Measures

Full Information

First Posted
June 24, 2019
Last Updated
August 30, 2023
Sponsor
Centre Hospitalier Departemental Vendee
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1. Study Identification

Unique Protocol Identification Number
NCT03998813
Brief Title
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
Acronym
TKAFTER
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
June 26, 2023 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Pain Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Locoregional analgesia by femoral triangle catheterization
Arm Type
Experimental
Arm Title
Tissue infiltration
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Locoregional analgesia by femoral triangle catheterization
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Tissue infiltration
Primary Outcome Measure Information:
Title
A walking pain assessment scale greater than or equal to 4
Description
Self-assessment scale to quantify the patient's pain on a virtual scale from 0 (no pain) to 10 (maximum pain imaginable)
Time Frame
Three months from the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme GUILLEY
Organizational Affiliation
CHD Vendée
Official's Role
Study Director
Facility Information:
Facility Name
Clinique Victor PAUCHET
City
Amiens
Country
France
Facility Name
Centre Hospitalier de Béthune Beuvry
City
Béthune
Country
France
Facility Name
Centre Hospitalier Départemental Vendée
City
La Roche-sur-Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hôpital des Diaconesses Croix Saint Simon
City
Paris
Country
France
Facility Name
Hôpital Privé Sévigné
City
Rennes
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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