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

Primary Purpose

Unilateral Primary Osteoarthritis of Knee

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Unilateral prosthetic knee surgery
Analgesia
Sponsored by
GCS Ramsay Santé pour l'Enseignement et la Recherche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Unilateral Primary Osteoarthritis of Knee

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Privé MédipôleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Block at the Adductor Canal + High Volume Local Infiltration Analgesia

Arm Description

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

Adductor canal block analgesia associated with surgical periarticular infiltration

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2023
Last Updated
May 22, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05715645
Brief Title
Assessment of Recovery After Adductor Canal Block Analgesia in Unilateral Prosthetic Knee Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Primary Osteoarthritis of Knee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patient and the people carrying out the functional assessments (physiotherapists) will be blinded to the analgesia received, unlike the investigator.
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule
Arm Type
Experimental
Arm Description
Adductor canal block analgesia associated with infiltration between the popliteal artery and the posterior capsule
Arm Title
Block at the Adductor Canal + High Volume Local Infiltration Analgesia
Arm Type
Active Comparator
Arm Description
Adductor canal block analgesia associated with surgical periarticular infiltration
Intervention Type
Procedure
Intervention Name(s)
Unilateral prosthetic knee surgery
Intervention Description
Unilateral prosthetic knee surgery
Intervention Type
Procedure
Intervention Name(s)
Analgesia
Intervention Description
Analgesic management by adductor canal block
Primary Outcome Measure Information:
Title
Post-operative recovery from knee prosthesis surgery
Description
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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon DEVILLEZ, MD
Phone
478940606
Ext
+33
Email
sdevillez@capio.fr
Facility Information:
Facility Name
Hôpital Privé Médipôle
City
Villeurbanne
ZIP/Postal Code
69100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon DEVILLEZ, MD
Email
sdevillez@capio.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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