Assessment of Recovery After Adductor Canal Block Analgesia in Unilateral Prosthetic Knee Surgery (IPACKNEE)

Assessment of Recovery After Adductor Canal Block Analgesia Associated Either With Infiltration Between Popliteal Artery and Posterior Capsule, or With Surgical Peri-articular Infiltration for Patients Treated by Improved Recovery Program

The purpose of the study is post-operative recovery from prosthetic knee surgery will be assessed by the proportion of patients entering the Accelerated Rehabilitation After Surgery program eligible for discharge from hospital at 2 days according to the following definition: Chung score ≥ 9 with no intravenous (IV) infusion, solid food, transit restored, no signs of infection and Cumulated Ambulation Score D1 ≥ 5 (if discharged on Day 1), Cumulated Ambulation Score Day 2 ≥ 10 (if discharged on Day 2), or Cumulated Ambulation Score Day 3 ≥ 11/18.

Study Overview

• Status: Completed
• Conditions: Unilateral Primary Osteoarthritis of Knee
• Intervention / Treatment: Procedure: Unilateral prosthetic knee surgery; Procedure: Analgesia

Detailed Description

This is a monocentric, interventional, prospective, comparative, randomized study in 2 parallel groups, single-blind. The study is proposed to the patient during the preoperative anesthetic consultation. The patient and the people carrying out the functional assessments (physiotherapists) will be blinded to the analgesia received, unlike the investigator.

Patients will be included by an anesthesiologist during the preoperative anesthetic consultation. After the Accelerated Rehabilitation After Surgery consultation, they will then be operated on (Day 0) and seen up to 5 times post-operatively over a period of 45 days for the purposes of the study: at 24h, 48h, 72h, discharge from hospital and 45 days post operative. Discharge from hospital occurs during follow-up depending on the patient's condition. These visits will coincide with follow-up consultations with the surgeon as part of the usual management.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Hôpital Privé Médipôle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient with a score "American Society of Anesthesiologists" I to III;
• Patient undergoing initial unilateral prosthetic knee replacement surgery for osteoarthritis;
• Patient eligible for analgesia by block of the adductor canal associated with additional infiltration;
• Patient accepting to follow the enhanced recovery program after surgery;
• Patient who signed an informed consent form to participate in the study.

Exclusion Criteria:

• Patient with a known allergy to a study product;
• Patient having undergone previous surgery with a prosthesis on the knee to be operated on;
• Patient with morbid obesity (Body Mass Index > 40);
• Patient with a pre-existing inability to walk;
• Patient with a history of chronic neuropathic pain in the leg undergoing surgery;
• Patient with heart failure with impaired ejection fraction;
• Patient with a history of drug addiction;
• Patient chronically taking level III analgesics;
• Patient taking gabapentin or pregabalin chronically;
• Patient with severe renal or hepatic impairment;
• Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group;
• Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
• Patient unable to understand the information related to the study (linguistic, psychological, cognitive reasons, etc.);
• Pregnant or likely to be pregnant (of childbearing age without effective contraception) or breastfeeding;
• Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
• Patient not benefiting from a social security scheme.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule; Adductor canal block analgesia associated with infiltration between the popliteal artery and the posterior capsule	Procedure: Unilateral prosthetic knee surgery; Unilateral prosthetic knee surgery; Procedure: Analgesia; Analgesic management by adductor canal block
Active Comparator: Block at the Adductor Canal + High Volume Local Infiltration Analgesia; Adductor canal block analgesia associated with surgical periarticular infiltration	Procedure: Unilateral prosthetic knee surgery; Unilateral prosthetic knee surgery; Procedure: Analgesia; Analgesic management by adductor canal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative recovery from knee prosthesis surgery	Post-operative recovery from prosthetic knee surgery will be assessed by the proportion of patients entering the Accelerated Rehabilitation After Surgery program eligible for discharge from hospital at 2 days according to the following definition: Chung score ≥ 9 with no intravenous (IV) infusion, solid food, transit restored, no signs of infection and Cumulated Ambulation Score D1 ≥ 5 (if discharged on Day 1), Cumulated Ambulation Score Day 2 ≥ 10 (if discharged on Day 2), or Cumulated Ambulation Score Day 3 ≥ 11/18.	3 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): March 19, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 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: 2022-A01884-39

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