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

Unilateral Primary Osteoarthritis of Knee Clinical Trial

— IPACKNEE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715645
• Other study ID #: 2022-A01884-39
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2023
• Est. completion date: January 2025

Study information

• Verified date: May 2023
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Simon DEVILLEZ, MD
• Phone: 478940606
• Email: sdevillez[@]capio.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Unilateral Primary Osteoarthritis of Knee

Intervention

Procedure:
• Unilateral prosthetic knee surgery
Unilateral prosthetic knee surgery
• Analgesia
Analgesic management by adductor canal block

Locations

Country	Name	City	State
France	Hôpital Privé Médipôle	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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