Infiltration or Nerve Blocks in Addition to Adductor Canal Block

NCT ID: NCT06920186

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-14

Study Completion Date

2027-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gonarthrosis Total Knee Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Category 2 Research Involving the Human Person (RIPH 2) :

Multi-center (2 sites), prospective, double-blind randomized, open-label 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
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1 of local analgesia protocol (PROSPECT recommandations)

Locoregional analgesia (LRA) protocol n°1 : adductor canal block + surgical infiltration (PROSPECT recommendations)

Group Type SHAM_COMPARATOR

Analgesia

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

Analgesia

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Analgesia

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

Intervention Type PROCEDURE

Analgesia

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Privé Claude Galien

Quincy-sous-Sénart, , France

Site Status

Clinique des Côtes du Rhône

Roussillon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yoann ELMALEH, MD

Role: primary

01 69 39 15 53 ext. 33

Raphaël LAURENT, MD

Role: primary

06.36.66.70.06 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-A02496-41

Identifier Type: OTHER

Identifier Source: secondary_id

COS-RGDS-2024-06-006-P-ELMALEH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.