Clinical trial NCT06920186: Infiltration or Nerve Blocks in Addition to Adductor Canal Block
Official title: Comparison of the Benefit of Peripheral Nerve Quadri-block Versus Adductor Canal Block + Surgical Infiltration in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gonarthrosis
Total Knee Arthroplasty
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Category 2 Research Involving the Human Person (RIPH 2) :

Single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing total knee arthroplasty according to locoregional analgesia (LRA) protocol :

* Group 1: adductor canal block + surgical infiltration
* Group 2: adductor canal block + femoro-cutaneous block + obturator block + IPACK block
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score
timeFrame: From enrollement to the last H24 after surgery
Secondary outcomes:
measure: Knee functional assessment
timeFrame: Hour 0
measure: Post operative pain
timeFrame: Hour 2
measure: Post operative pain
timeFrame: Hour 6
measure: Post operative pain
timeFrame: Hour 12
measure: First ambulation
timeFrame: Hour 12
measure: Post operative pain
timeFrame: Hour 24
measure: Joint range of both knees
timeFrame: Hour 24
measure: First ambulation
timeFrame: Hour 24
measure: Post operative pain
timeFrame: Hour 48
measure: Quality of recovery
timeFrame: Hour 48
measure: Opioid drug use
timeFrame: Hour 48
measure: Non-opioid drug use
timeFrame: Hour 48
measure: Joint range of both knees
timeFrame: Hour 48
measure: First ambulation
timeFrame: Hour 48
measure: Length of stay in the post-intervention monitoring room
timeFrame: Hour 48
measure: Post operative pain
timeFrame: Month 1
measure: Joint range of both knees
timeFrame: Month 1
measure: Length of hospitalisation
timeFrame: Month 1
measure: Return to patient usual activities
timeFrame: Month 1
measure: Drug tolerance
timeFrame: Month 1
measure: Patient comfort
timeFrame: Hour 1
measure: Knee functional assessment
timeFrame: Month 1
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References: