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

Not Applicable

Recruiting

• Conditions: Unilateral Primary Osteoarthritis of Knee
• Interventions: Procedure: Unilateral prosthetic knee surgery; Procedure: Analgesia

• Registration Number: NCT05715645
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-06
• Study First Posted: 2023-02-08
• Study Start: 2023-04-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule	Analgesia	Adductor canal block analgesia associated with infiltration between the popliteal artery and the posterior capsule
Block at the Adductor Canal + High Volume Local Infiltration Analgesia	Unilateral prosthetic knee surgery	Adductor canal block analgesia associated with surgical periarticular infiltration
Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule	Unilateral prosthetic knee surgery	Adductor canal block analgesia associated with infiltration between the popliteal artery and the posterior capsule
Block at the Adductor Canal + High Volume Local Infiltration Analgesia	Analgesia	Adductor canal block analgesia associated with surgical periarticular infiltration

Primary Outcome Measures

Name	Time	Method
Post-operative recovery from knee prosthesis surgery	3 days	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.

Trial Locations

Locations (1)

Hôpital Privé Médipôle; 🇫🇷 Villeurbanne, France