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

NCT05715645 | Completed

• 1 other identifier: 2022-A01884-39
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Primary Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule

EXPERIMENTAL

Adductor canal block analgesia associated with infiltration between the popliteal artery and the posterior capsule

Procedure: Unilateral prosthetic knee surgery; Procedure: Analgesia

Block at the Adductor Canal + High Volume Local Infiltration Analgesia

ACTIVE COMPARATOR

Adductor canal block analgesia associated with surgical periarticular infiltration

Procedure: Unilateral prosthetic knee surgery; Procedure: Analgesia

Interventions

Unilateral prosthetic knee surgery PROCEDURE

Unilateral prosthetic knee surgery

Block at the Adductor Canal + High Volume Local Infiltration Analgesia; Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule

Analgesia PROCEDURE

Analgesic management by adductor canal block

Block at the Adductor Canal + High Volume Local Infiltration Analgesia; Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 not benefiting from a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Médipôle

Villeurbanne, 69100, France

Location

MeSH Terms

Interventions

Analgesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient and the people carrying out the functional assessments (physiotherapists) will be blinded to the analgesia received, unlike the investigator.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 8, 2023
• Study Start: April 5, 2023
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)