Gonarthrosis, Total Knee Arthroplasty
Conditions
Brief summary
The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).
Detailed description
In addition to the adductor canal block, this quadruple block incorporates : 1. the block of the lateral cutaneous nerve of the thigh (or femoral-cutaneous nerve), which is a collateral sensory branch of the posterior part of the lumbar plexus. 2. IPACK (Infiltration between Popliteal Artery and Capsule of Knee), designed as a motor-sparing technique (targeting the sensory articular branches of the sciatic nerve and avoiding the motor branches of the tibial and fibular nerves), is particularly effective on posterior pain. 3. obturator nerve block, a mixed nerve originating from the anterior part of the lumbar plexus. It divides into two branches: anterior, which innervates the adductor longus, adductor brevis and gracilis muscles, and posterior, which innervates the medial part of the knee joint and the posteromedial part of the thigh. It provides sensitivity to the medial aspect of the thigh.
Interventions
PROCEDUREAnalgesia
1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Category 2 Research Involving the Human Person (RIPH 2) : Multi-center (2 sites), prospective, double-blind randomized, study of two parallel groups of patients undergoing total knee arthroplasty according to locoregional analgesia (LRA) protocol : * Group 1: Real adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum * Group 2: Real adductor canal block + femoro-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female * Patient with signed consent to participate in the study, * Patient with uni or bilateral primary gonarthrosis * Indication for total knee arthroplasty.
Exclusion criteria
* History of knee fracture, arthroplasty or osteotomy * Known or unknown contraindication to ALR or locoregional anesthesia products * Neurological disease, stroke sequelae * Mental deficiency or any other reason that may hinder understanding or strict application of the protocol * Patient not affiliated to the French social security system * Patient under court protection, guardianship or curatorship * Pregnant or potentially pregnant women (women of childbearing age without effective contraception) * Patient already included in another therapeutic study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score | From enrollement to the last H24 after surgery | The QoR-15 score at H24 after surgery was compared between the two groups for primary endpoint analysis. The QoR-15 accurately measures postoperative recovery by focusing on 5 key domains: pain, physical comfort, physical independence, psychological support and emotional state. Each item is rated from 0 (unfavorable) to 10 (favorable), with an overall score corresponding to the sum of the score obtained for each item, i.e. a score from 0 (no recovery) to 150 (full recovery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee functional assessment | Hour 0 | Functional assessment of the knee with KOOS JR questionnaire |
| Post operative pain | Hour 2 | Pain measured with a simple numeric scale |
| First ambulation | Hour 12 | time between end of intervention and first ambulation |
| Joint range of both knees | Hour 24 | Measurement of the joint range of both knees |
| Quality of recovery | Hour 48 | Quality of recovery measured with QoR 15 questionnaire |
| Opioid drug use | Hour 48 | Opioid drug use evaluation |
| Non-opioid drug use | Hour 48 | Non-opioid drug use evaluation |
| Length of stay in the post-intervention monitoring room | Hour 48 | Length of stay in the post-intervention monitoring room |
| Length of hospitalisation | Month 1 | Length of hospitalisation |
| Return to patient usual activities | Month 1 | Time taken for the patient to return to their usual activities |
| Drug tolerance | Month 1 | Drug tolerance |
| Patient comfort | Hour 1 | Patient comfort during loco-regional anesthesia |
Countries
France
Outcome results
None listed