Unilateral Primary Osteoarthritis of KneeIPACKNEENCT05715645
Assessment of Recovery After Adductor Canal Block Analgesia in Unilateral Prosthetic Knee Surgery
A study testing Unilateral prosthetic knee surgery and Analgesia in people with Unilateral Primary Osteoarthritis of Knee, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unilateral Primary Osteoarthritis of Knee
- What is being tested?
- Unilateral prosthetic knee surgery and Analgesia
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2023to 19 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Unilateral prosthetic knee surgery, Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral prosthetic knee surgeryProcedure or surgery
Unilateral prosthetic knee surgery
AnalgesiaProcedure or surgery
Analgesic management by adductor canal block
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Unilateral prosthetic knee surgery; Procedure: Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Apr 2023
- Primary completion19 Mar 2025
- Study completion19 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Primary Osteoarthritis of KneeStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715645
- Sponsor's protocol ID
- 2022-A01884-39
- Acronym
- IPACKNEE
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05715645
- Acronym / sponsor ID
- IPACKNEE / 2022-A01884-39
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 19 Mar 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule | Experimental | Procedure: Unilateral prosthetic knee surgery, Procedure: AnalgesiaAdductor canal block analgesia associated with infiltration between the popliteal artery and the posterior capsule |
| Block at the Adductor Canal + High Volume Local Infiltration Analgesia | Active comparator | Procedure: Unilateral prosthetic knee surgery, Procedure: AnalgesiaAdductor canal block analgesia associated with surgical periarticular infiltration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral prosthetic knee surgeryUnilateral prosthetic knee surgery | Procedure or surgery | Block at the Adductor Canal + High Volume Local Infiltration Analgesia, Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule |
| AnalgesiaAnalgesic management by adductor canal block | Procedure or surgery | Block at the Adductor Canal + High Volume Local Infiltration Analgesia, Block at the Adductor Canal + Infiltration between Popliteal Artery and Posterior Capsule |
Primary outcome
Post-operative recovery from knee prosthesis surgery
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral prosthetic knee surgery and Analgesia in people with Unilateral Primary Osteoarthritis of Knee, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative recovery from knee prosthesis surgery (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.