Infiltration or Nerve Blocks in Addition to Adductor Canal Block

N/ARecruitingNCT06920186

GCS Ramsay Santé pour l'Enseignement et la Recherche100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

100

Conditions

Gonarthrosis Total Knee Arthroplasty

Interventions

AnalgesiaPROCEDURE

1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum

AnalgesiaPROCEDURE

2- Real Adductor canal block + femoral-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, France

RECRUITING

Clinique des Côtes du Rhône

Roussillon, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score

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).

Time frame: From enrollement to the last H24 after surgery

Secondary Outcomes

Knee functional assessment

Functional assessment of the knee with KOOS JR questionnaire

Time frame: Hour 0

Post operative pain

Pain measured with a simple numeric scale

Time frame: Hour 2

Post operative pain

Pain measured with a simple numeric scale

Time frame: Hour 6

Post operative pain

Pain measured with a simple numeric scale

Time frame: Hour 12

First ambulation

time between end of intervention and first ambulation

Time frame: Hour 12

Post operative pain

Pain measured with a simple numeric scale

Time frame: Hour 24

Joint range of both knees

Data from ClinicalTrials.gov

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