Infiltration or Nerve Blocks in Addition to Adductor Canal Block (INCA)

Comparison of the Benefit of Peripheral Nerve Quadri-block Versus Adductor Canal Block + Surgical Infiltration in Total Knee Arthroplasty

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Gonarthrosis; Total Knee Arthroplasty
• Intervention / Treatment: Procedure: Analgesia; Procedure: Analgesia

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Quincy-sous-Sénart, France, 91480
    • Hôpital privé Claude Galien
    • Contact: Yoann ELMALEH, MD; Phone Number: 33 01 69 39 15 53; Email: yoann.d.elmaleh@gmail.com
  • Roussillon, France, 38150
    • Clinique des Côtes du Rhône
    • Contact: Raphaël LAURENT, MD; Phone Number: +33 06.36.66.70.06; Email: r.laurent@quincyanesthesie.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group 1 of local analgesia protocol (PROSPECT recommandations); Locoregional analgesia (LRA) protocol n°1 : adductor canal block + surgical infiltration (PROSPECT recommendations)	Procedure: Analgesia; 1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum; Procedure: Analgesia; 2- Real Adductor canal block + femoral-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum
Experimental: Group 2 of local analgesia protocol (quadri-peripheral nerve block ); Locoregional analgesia (LRA) protocol n° 2 : adductor canal block + femoral-cutaneous block + obturator block + IPACK block	Procedure: Analgesia; 1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum; Procedure: Analgesia; 2- Real Adductor canal block + femoral-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollement to the last H24 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee functional assessment	Functional assessment of the knee with KOOS JR questionnaire	Hour 0
Post operative pain	Pain measured with a simple numeric scale	Hour 2
Post operative pain	Pain measured with a simple numeric scale	Hour 6
Post operative pain	Pain measured with a simple numeric scale	Hour 12
First ambulation	time between end of intervention and first ambulation	Hour 12
Post operative pain	Pain measured with a simple numeric scale	Hour 24
Joint range of both knees	Measurement of the joint range of both knees	Hour 24
First ambulation	time between end of intervention and first ambulation	Hour 24
Post operative pain	Pain measured with a simple numeric scale	Hour 48
Quality of recovery	Quality of recovery measured with QoR 15 questionnaire	Hour 48
Opioid drug use	Opioid drug use evaluation	Hour 48
Non-opioid drug use	Non-opioid drug use evaluation	Hour 48
Joint range of both knees	Measurement of the joint range of both knees	Hour 48
First ambulation	time between end of intervention and first ambulation	Hour 48
Length of stay in the post-intervention monitoring room	Length of stay in the post-intervention monitoring room	Hour 48
Post operative pain	Pain measured with a simple numeric scale	Month 1
Joint range of both knees	Measurement of the joint range of both knees	Month 1
Length of hospitalisation	Length of hospitalisation	Month 1
Return to patient usual activities	Time taken for the patient to return to their usual activities	Month 1
Drug tolerance	Drug tolerance	Month 1
Patient comfort	Patient comfort during loco-regional anesthesia	Hour 1
Knee functional assessment	Functional assessment of the knee with KOOS JR questionnaire	Month 1

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Estimated): January 14, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Anesthesia and Analgesia; Analgesia
• Other Study ID Numbers: COS-RGDS-2024-06-006-P-ELMALEH; 2024-A02496-41 (Other Identifier: N° ID-RCB (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No