GonarthrosisINCANCT06920186
Infiltration or Nerve Blocks in Addition to Adductor Canal Block
A study testing Analgesia in people with Gonarthrosis and Total Knee Arthroplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites in France.
Trial summary
The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis, Total Knee Arthroplasty
- What is being tested?
- Analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 4 May 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female
- Patient with signed consent to participate in the study,
- Patient with uni or bilateral primary gonarthrosis
- Indication for total knee arthroplasty.
Who cannot join
- History of knee fracture, arthroplasty or osteotomy
- Known or unknown contraindication to ALR or locoregional anesthesia products
- Neurological disease, stroke sequelae
- Mental deficiency or any other reason that may hinder understanding or strict application of the protocol
- Patient not affiliated to the French social security system
- Patient under court protection, guardianship or curatorship
- Pregnant or potentially pregnant women (women of childbearing age without effective contraception)
- Patient already included in another therapeutic study protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Yoann ELMALEH, MD, 01 69 39 15 53 ext. 33, yoann.d.elmaleh@gmail.com
- Not yet recruiting
Clinique des Côtes du Rhône
Roussillon, 38150
Raphaël LAURENT, MD, 06.36.66.70.06 ext. +33, r.laurent@quincyanesthesie.com
About this study
Official title: Comparison of the Benefit of Peripheral Nerve Quadri-block Versus Adductor Canal Block + Surgical Infiltration in Total Knee Arthroplasty
The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).
Read the detailed description
In addition to the adductor canal block, this quadruple block incorporates :
- the block of the lateral cutaneous nerve of the thigh (or femoral-cutaneous nerve), which is a collateral sensory branch of the posterior part of the lumbar plexus.
- IPACK (Infiltration between Popliteal Artery and Capsule of Knee), designed as a motor-sparing technique (targeting the sensory articular branches of the sciatic nerve and avoiding the motor branches of the tibial and fibular nerves), is particularly effective on posterior pain.
- obturator nerve block, a mixed nerve originating from the anterior part of the lumbar plexus. It divides into two branches: anterior, which innervates the adductor longus, adductor brevis and gracilis muscles, and posterior, which innervates the medial part of the knee joint and the posteromedial part of the thigh. It provides sensitivity to the medial aspect of the thigh.
- Conditions
- Gonarthrosis, Total Knee Arthroplasty
- Being tested
- Analgesia
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnalgesiaProcedure or surgery
1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum
AnalgesiaProcedure or surgery
2- Real Adductor canal block + femoral-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum
| Study group | Role | What they receive |
|---|---|---|
| Group 1 of local analgesia protocol (PROSPECT recommandations) | Sham comparator | Locoregional analgesia (LRA) protocol n°1 : adductor canal block + surgical infiltration (PROSPECT recommendations) Receives: Procedure: Analgesia |
| Group 2 of local analgesia protocol (quadri-peripheral nerve block ) | Experimental | Locoregional analgesia (LRA) protocol n° 2 : adductor canal block + femoral-cutaneous block + obturator block + IPACK block Receives: Procedure: Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score
The QoR-15 score at H24 after surgery was compared between the two groups for primary endpoint analysis.
The QoR-15 accurately measures postoperative recovery by focusing on 5 key domains: pain, physical comfort, physical independence, psychological support and emotional state. Each item is rated from 0 (unfavorable) to 10 (favorable), with an overall score corresponding to the sum of the score obtained for each item, i.e. a score from 0 (no recovery) to 150 (full recovery).
Measured: From enrollement to the last H24 after surgery
Secondary outcomes (22)
Knee functional assessment
Functional assessment of the knee with KOOS JR questionnaire
Measured: Hour 0
Post operative pain
Pain measured with a simple numeric scale
Measured: Hour 2
Post operative pain
Pain measured with a simple numeric scale
Measured: Hour 6
Post operative pain
Pain measured with a simple numeric scale
Measured: Hour 12
First ambulation
time between end of intervention and first ambulation
Measured: Hour 12
Post operative pain
Pain measured with a simple numeric scale
Measured: Hour 24
Joint range of both knees
Measurement of the joint range of both knees
Measured: Hour 24
First ambulation
time between end of intervention and first ambulation
Measured: Hour 24
Post operative pain
Pain measured with a simple numeric scale
Measured: Hour 48
Quality of recovery
Quality of recovery measured with QoR 15 questionnaire
Measured: Hour 48
Opioid drug use
Opioid drug use evaluation
Measured: Hour 48
Non-opioid drug use
Non-opioid drug use evaluation
Measured: Hour 48
Joint range of both knees
Measurement of the joint range of both knees
Measured: Hour 48
First ambulation
time between end of intervention and first ambulation
Measured: Hour 48
Length of stay in the post-intervention monitoring room
Length of stay in the post-intervention monitoring room
Measured: Hour 48
Post operative pain
Pain measured with a simple numeric scale
Measured: Month 1
Joint range of both knees
Measurement of the joint range of both knees
Measured: Month 1
Length of hospitalisation
Length of hospitalisation
Measured: Month 1
Return to patient usual activities
Time taken for the patient to return to their usual activities
Measured: Month 1
Drug tolerance
Drug tolerance
Measured: Month 1
Patient comfort
Patient comfort during loco-regional anesthesia
Measured: Hour 1
Knee functional assessment
Functional assessment of the knee with KOOS JR questionnaire
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start4 May 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GonarthrosisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Category 2 Research Involving the Human Person (RIPH 2) : Multi-center (2 sites), prospective, double-blind randomized, study of two parallel groups of patients undergoing total knee arthroplasty according to locoregional analgesia (LRA) protocol : * Group 1: Real adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum * Group 2: Real adductor canal block + femoro-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920186
- Sponsor's protocol ID
- COS-RGDS-2024-06-006-P-ELMALEH
- Other IDs
- 2024-A02496-41
- Acronym
- INCA
- Status last verified
- Jun 2026
- First submitted
- 24 Mar 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elmaleh Y, Maupain O, Guessous K, Kattou F, Laurent R, Giral T, Garnier T, Delvaux B. Comparison of a four-nerve block protocol versus adductor canal block plus local infiltration analgesia for primary total knee arthroplasty in two French private hospitals: protocol for the multicentre randomised INCA trial. BMJ Open. 2026 Jul 21;16(7):e119093. doi: 10.1136/bmjopen-2026-119093.
PubMed 42481203
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Benefit of Peripheral Nerve Quadri-block Versus Adductor Canal Block + Surgical Infiltration in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06920186
- Acronym / sponsor ID
- INCA / COS-RGDS-2024-06-006-P-ELMALEH
- Conditions
- Gonarthrosis, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Apr 2025 (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 aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).
Detailed description
In addition to the adductor canal block, this quadruple block incorporates :
- the block of the lateral cutaneous nerve of the thigh (or femoral-cutaneous nerve), which is a collateral sensory branch of the posterior part of the lumbar plexus.
- IPACK (Infiltration between Popliteal Artery and Capsule of Knee), designed as a motor-sparing technique (targeting the sensory articular branches of the sciatic nerve and avoiding the motor branches of the tibial and fibular nerves), is particularly effective on posterior pain.
- obturator nerve block, a mixed nerve originating from the anterior part of the lumbar plexus. It divides into two branches: anterior, which innervates the adductor longus, adductor brevis and gracilis muscles, and posterior, which innervates the medial part of the knee joint and the posteromedial part of the thigh. It provides sensitivity to the medial aspect of the thigh.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Category 2 Research Involving the Human Person (RIPH 2) : Multi-center (2 sites), prospective, double-blind randomized, study of two parallel groups of patients undergoing total knee arthroplasty according to locoregional analgesia (LRA) protocol : * Group 1: Real adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum * Group 2: Real adductor canal block + femoro-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum
| Arm | Type | Receives |
|---|---|---|
| Group 1 of local analgesia protocol (PROSPECT recommandations) | Sham comparator | Procedure: AnalgesiaLocoregional analgesia (LRA) protocol n°1 : adductor canal block + surgical infiltration (PROSPECT recommendations) |
| Group 2 of local analgesia protocol (quadri-peripheral nerve block ) | Experimental | Procedure: AnalgesiaLocoregional analgesia (LRA) protocol n° 2 : adductor canal block + femoral-cutaneous block + obturator block + IPACK block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult male or female
- Patient with signed consent to participate in the study,
- Patient with uni or bilateral primary gonarthrosis
- Indication for total knee arthroplasty.
Key exclusion criteria (8 listed)
- History of knee fracture, arthroplasty or osteotomy
- Known or unknown contraindication to ALR or locoregional anesthesia products
- Neurological disease, stroke sequelae
- Mental deficiency or any other reason that may hinder understanding or strict application of the protocol
- Patient not affiliated to the French social security system
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 |
|---|---|---|
| Analgesia1- Real Adductor canal block + surgical infiltration and sham of femoro-cutaneous block + obturator block + IPACK block with physiological serum | Procedure or surgery | Group 1 of local analgesia protocol (PROSPECT recommandations) |
| Analgesia2- Real Adductor canal block + femoral-cutaneous block + obturator block + IPACK block and sham of surgical infiltration with physiological serum | Procedure or surgery | Group 2 of local analgesia protocol (quadri-peripheral nerve block ) |
Primary outcome
Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score
Time frame: From enrollement to the last H24 after surgery
The QoR-15 score at H24 after surgery was compared between the two groups for primary endpoint analysis. The QoR-15 accurately measures postoperative recovery by focusing on 5 key domains: pain, physical comfort, physical independence, psychological support and emotional state. Each item is rated from 0 (unfavorable) to 10 (favorable), with an overall score corresponding to the sum of the score obtained for each item, i.e. a score from 0 (no recovery) to 150 (full recovery).
22 secondary outcomes
Knee functional assessment
Time frame: Hour 0
Post operative pain
Time frame: Hour 2
Post operative pain
Time frame: Hour 6
Post operative pain
Time frame: Hour 12
First ambulation
Time frame: Hour 12
Post operative pain
Time frame: Hour 24
Joint range of both knees
Time frame: Hour 24
First ambulation
Time frame: Hour 24
Post operative pain
Time frame: Hour 48
Quality of recovery
Time frame: Hour 48
Opioid drug use
Time frame: Hour 48
Non-opioid drug use
Time frame: Hour 48
Joint range of both knees
Time frame: Hour 48
First ambulation
Time frame: Hour 48
Length of stay in the post-intervention monitoring room
Time frame: Hour 48
Post operative pain
Time frame: Month 1
Joint range of both knees
Time frame: Month 1
Length of hospitalisation
Time frame: Month 1
Return to patient usual activities
Time frame: Month 1
Drug tolerance
Time frame: Month 1
Patient comfort
Time frame: Hour 1
Knee functional assessment
Time frame: Month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 42481203Elmaleh Y, Maupain O, Guessous K, Kattou F, Laurent R, Giral T, Garnier T, Delvaux B. Comparison of a four-nerve block protocol versus adductor canal block plus local infiltration analgesia for primary total knee arthroplasty in two French private hospitals: protocol for the multicentre randomised INCA trial. BMJ Open. 2026 Jul 21;16(7):e119093. doi: 10.1136/bmjopen-2026-119093.
- 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.
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analgesia in people with Gonarthrosis and Total Knee Arthroplasty, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 2 sites 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's recovery at H24 as after surgery assessed by the QoR-15 (Quality of Recovery) questionnaire score (time frame: From enrollement to the last H24 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920186, which also lists 1 linked publication.
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 5 Jun 2026.