AnalgesicPhase 3SALIANCT03620136
Comparison of Two Techniques of Locoregional Analgesia in Total Knee Prosthesis Surgery : Block to the Adductor Channel Versus Peri-articular Local Infiltrations
A Phase 3 study testing locoregional analgesia by a block on the adductor channel and locoregional analgesia by periarticular local infiltrations in people with Analgesic, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The post-operative pain generated by prosthetic knee replacement surgery is known to be moderate to severe during two or three days following surgery. The most popular analgesic technique after prosthetic knee replacement surgery remains the femoral block (FB), whether in single injection or continuous infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesic
- What is being tested?
- locoregional analgesia by a block on the adductor channel and locoregional analgesia by periarticular local infiltrations
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 7 Feb 2018to 28 Nov 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients (≥18 years),
- Having an American Society of Anesthesiology score (ASA) I to III
- To benefit from first and unilateral prosthetic replacement surgery of knee under spinal anesthesia,
- Having social security scheme,
- Having received informed information and having signed informed consent
Who cannot join
- Pregnant women (diagnosis of interrogation),
- Breastfeeding women
- Patients under tutorship or curatorship,
- Persons who can not receive sufficient information because of disturbances of superior functions or because of insufficient command of the French language according to the judgment of the investigator,
- A history of chronic neuropathic pain in the leg to be operated on,
- Patients who have undergone prior surgery on the knee to perform surgery,
Show all 18Show fewer
- Contra-indication to loco-regional anesthesia: known allergy to local anesthetics,
- Contra-indication to the use of ROPIVACAINE: known hypersensitivity to the active substance or other amide-linked local anesthetics, hypovolemia
- A morbid obesity (Body Mass Index (BMI)> 40),
- Severe renal insufficiency (Glomerular Filtration Rate (GFR) <30mL / min),
- Severe hepatic impairment (prothrombin rate PR <50%),
- Heart failure (left ventricular ejection fraction (LVEF)<40%),
- Transplanted patients,
- A history of drug abuse,
- The taking of chronic morphine for 6 months in systematic,
- Any inability to understand visual scale,
- An inability to walk pre-existing,
- Participation in other interventional research, excluding physiological studies and other interventional research that does not interfere with the analysis of the primary endpoint (as determined by the investigator).
Trial locations and contacts
1 site in 1 country.
About this study
The post-operative pain generated by prosthetic knee replacement surgery is known to be moderate to severe during two or three days following surgery.
The most popular analgesic technique after prosthetic knee replacement surgery remains the femoral block (FB), whether in single injection or continuous infusion. In major knee surgery, FBs provide better analgesia compared to systemic morphine and FBs provide the same analgesia that obtained with epidural analgesia but with fewer associated adverse effects.
Read more
Although FBs provide excellent post-operative analgesia after total knee prosthesis, they also provide a significant quadricepsia weakness that increases the risk of severe falls and complications, and hinders the rapid rehabilitation process. For these reasons, alternative analgesic techniques have emerged in recent years.
To avoid the quadricipital motor block generated by FBs, some authors proposed the administration of local anesthetics in the adductor channel, also known as the Hunter channel, in order to produce a pure sensory block. With the development of ultrasound, the adductor channel is easily visualized in the middle of the thigh. This allows the adductor channel block (ACB) to be realized with a high success rate. ACB appears to decrease postoperative pain and morphine consumption. It also significantly improves the ability of patients to walk around after Total Knee Arthroplasty (TKA) surgery.
With the same goal of quadricipital savings, the use of the analgesic technique by periarticular infiltration of local anesthetics (ILA) has spread in recent years, due to the fact that an analgesic technique of simple realization and without apparent danger, and this despite limited evidence of its effectiveness.
The Croix-Rousse Hospital is a university hospital in Lyon with a highly developed orthopedic surgery center, producing approximately 550 TKA per year. During the year 2016, approximately half were benefited from post-operative analgesia management by ACB, and the other half by the implementation of the ILA.
To date few studies have been interested in comparing these two analgesic techniques in knee prosthesis surgery.
- Conditions
- Analgesic
- Being tested
- locoregional analgesia by a block on the adductor channel, locoregional analgesia by periarticular local infiltrations
- Keywords
- Total knee prosthesis, Adductor canal block, Local peri-articular infiltrations, Postoperative analgesia, Early rehabilitation, Patient Controlled Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
locoregional analgesia by a block on the adductor channelDrug
The block at the adductor channel will be realized under echo guidance, before the spinal anesthesia, by puncture at the upper 1/3 of the thigh. It will be used echogenic needle adapted to the morphotype of each patient, of varying length from 50mm to 100mm. A single injection of 20mL of ROPIVACAINE 2mg / ml, the efficacy of which should be checked before spinal anesthesia is performed by a cold test.
Knee analgesia will be supplemented by per-operative infiltration of 50mL of ROPIVACAINE 2mg / ml at the posterior capsule, once the surfaces joints prepared to accommodate the prosthesis and by two placebo infiltrations of 50mL each of physiological saline in the medial and lateral ligaments and in the edges of the incision.
locoregional analgesia by periarticular local infiltrationsDrug
A placebo injection to the adductor channel of 20 mL of physiological serum will be performed in the pre-induction room before surgery, according to the same procedures as the patients of the ACB group.
During the surgical procedure, patients in the ILA group will receive a total dose of 300mg of ROPIVACAINE 2mg / ml in the form of 3 periarticular injections. The first injection of 50mL of ROPIVACAINE 2mg / ml will be made once the articular surfaces are prepared to receive the prosthesis, at the level of the posterior capsule. The second injection of 50mL of ROPIVACAINE 2mg / ml will be performed once the total knee prosthesis is installed, in the medial and lateral ligaments. Finally, the last injection will also include 50mL of ROPIVACAINE 2mg / ml and will be made in the edges of the incision at the time of closure.
| Study group | Role | What they receive |
|---|---|---|
| locoregional analgesia by a block on the adductor channel | Experimental | Not described Receives: Drug: locoregional analgesia by a block on the adductor channel |
| locoregional analgesia by periarticular local infiltrations | Experimental | Not described Receives: Drug: locoregional analgesia by periarticular local infiltrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative consumption of MORPHINE
cumulative dose of morphine (miligrams). The administration of morphine will be done using a self-controlled analgesic pump (PCA). It will be made available to the patient when he leaves the block. The PCA allows the patient to adapt his consumption of morphine to his needs in analgesics. A nurse regularly reports the amount of morphine that the patient has administered.
Measured: during the first 48 hours following the surgical incision
Secondary outcomes (10)
Pain at rest
Postoperative pain will be assessed by a visual scale, graded from 0 to 10, where 0 is a total absence of pain and 10 is the maximum pain. Pain at rest will be measured by the paramedical team
Measured: Resting pain will be measured every 4 hours in the first 24 hours, then every 8 hours between 24 and 72 hours
pain in movement
Postoperative pain will be assessed by a visual scale, graded from 0 to 10, where 0 is a total absence of pain and 10 is the maximum pain.
The movement pain will be assessed daily by the team of physiotherapists for orthostatism, walking, and maximum flexion of the operated knee.
Measured: at day 3
quality of the analgesia offered by the ACB
the consumption of MORPHINE will be analyzed from different angles in order to evaluate the quality of the analgesia offered by the ACB.
It will therefore be observed in the ACB group, the time between injection to the adductor channel and the first dose requested on the PCA.
Measured: within 48 hours after the injection to the adductor channel
quality of the analgesia offered by the ILA
the consumption of MORPHINE will be analyzed from different angles in order to evaluate the quality of the analgesia offered by the ILA.
It will be observed the delay between the end of surgery and the use of a first dose of MORPHINE on PCA.
Measured: within 48 hours after the end of surgery
quality of the analgesia
the curve of consumption of morphine over time from H0 (surgical incision time) to H48 will be established for the 2 arms
Measured: within 48 hours after the surgical incision time
Functional capabilities and rehabilitation
The evaluation of the quality and the precocity of the postoperative rehabilitation of the patients will be carried out by the daily measurement of the CAS score (Cumulated Ambulation Score). This score is a validated tool in orthopedic surgery to evaluate daily the recovery of the basic mobility of the patients until return to an autonomy allowing their return home.
Measured: at day 3
Duration of hospitalization
The total duration of hospitalization will be reported after the patient has left, whether it is a return home, or a transfer to a rehabilitation center
Measured: at day 3
Patient satisfaction
overall satisfaction and satisfaction with pain management will be assessed for each patient using a visual scale where 0 is a completely dissatisfied patient and 10 is a fully satisfied patient
Measured: at day 3
Secondary complications due to adductor channel block
All complications related to this gesture should be reported in the case report form : failure (specify the reason), vagal malaise, suspicion of intravenous injection and suspicion of intravascular injection.
Measured: Day 0 : At the time of the ACB in the pre-induction room
Complications secondary to analgesic medications and surgery
Adverse effects associated with the use of MORPHINE, the administration of local anesthetics and related to surgery will be reported in the case report form.
Measured: at day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start7 Feb 2018
- Primary completion27 Nov 2019
- Study completion28 Nov 2019
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 AnalgesicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline Macabeo, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620136
- Sponsor's protocol ID
- 69HCL16_0798
- Other IDs
- 2016-005213-53, 2016
- Acronym
- SALIA
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2017
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pic C, Macabeo C, Waissi E, Lasselin P, Raffin M, Pradat P, Lalande L, Lustig S, Aubrun F, Dziadzko M. No Benefit of Adductor Canal Block Compared with Anterior Local Infiltration Analgesia in Primary Total Knee Arthroplasty: A Single-Blinded Randomized Controlled Clinical Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):231-238. doi: 10.2106/JBJS.22.00745. Epub 2022 Nov 18.
PubMed 36723467
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Techniques of Locoregional Analgesia in Total Knee Prosthesis Surgery : Block to the Adductor Channel Versus Peri-articular Local Infiltrations
- ClinicalTrials.gov ID
- NCT03620136
- Acronym / sponsor ID
- SALIA / 69HCL16_0798
- Conditions
- Analgesic
- Keywords
- Total knee prosthesis, Adductor canal block, Local peri-articular infiltrations, Postoperative analgesia, Early rehabilitation, Patient Controlled Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 8 Aug 2018 (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 post-operative pain generated by prosthetic knee replacement surgery is known to be moderate to severe during two or three days following surgery.
The most popular analgesic technique after prosthetic knee replacement surgery remains the femoral block (FB), whether in single injection or continuous infusion. In major knee surgery, FBs provide better analgesia compared to systemic morphine and FBs provide the same analgesia that obtained with epidural analgesia but with fewer associated adverse effects.
Although FBs provide excellent post-operative analgesia after total knee prosthesis, they also provide a significant quadricepsia weakness that increases the risk of severe falls and complications, and hinders the rapid rehabilitation process. For these reasons, alternative analgesic techniques have emerged in recent years.
To avoid the quadricipital motor block generated by FBs, some authors proposed the administration of local anesthetics in the adductor channel, also known as the Hunter channel, in order to produce a pure sensory block. With the development of ultrasound, the adductor channel is easily visualized in the middle of the thigh. This allows the adductor channel block (ACB) to be realized with a high success rate. ACB appears to decrease postoperative pain and morphine consumption. It also significantly improves the ability of patients to walk around after Total Knee Arthroplasty (TKA) surgery.
With the same goal of quadricipital savings, the use of the analgesic technique by periarticular infiltration of local anesthetics (ILA) has spread in recent years, due to the fact that an analgesic technique of simple realization and without apparent danger, and this despite limited evidence of its effectiveness.
The Croix-Rousse Hospital is a university hospital in Lyon with a highly developed orthopedic surgery center, producing approximately 550 TKA per year. During the year 2016, approximately half were benefited from post-operative analgesia management by ACB, and the other half by the implementation of the ILA.
To date few studies have been interested in comparing these two analgesic techniques in knee prosthesis surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| locoregional analgesia by a block on the adductor channel | Experimental | Drug: locoregional analgesia by a block on the adductor channel |
| locoregional analgesia by periarticular local infiltrations | Experimental | Drug: locoregional analgesia by periarticular local infiltrations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Major patients (≥18 years),
- Having an American Society of Anesthesiology score (ASA) I to III
- To benefit from first and unilateral prosthetic replacement surgery of knee under spinal anesthesia,
- Having social security scheme,
- Having received informed information and having signed informed consent
Key exclusion criteria (18 listed)
- Pregnant women (diagnosis of interrogation),
- Breastfeeding women
- Patients under tutorship or curatorship,
- Persons who can not receive sufficient information because of disturbances of superior functions or because of insufficient command of the French language according to the judgment of the investigator,
- A history of chronic neuropathic pain in the leg to be operated on,
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 |
|---|---|---|
| locoregional analgesia by a block on the adductor channelThe block at the adductor channel will be realized under echo guidance, before the spinal anesthesia, by puncture at the upper 1/3 of the thigh. It will be used echogenic needle adapted to the morphotype of each patient, of varying length from 50mm to 100mm. A single injection of 20mL of ROPIVACAINE 2mg / ml, the efficacy of which should be checked before spinal anesthesia is performed by a cold test. Knee analgesia will be supplemented by per-operative infiltration of 50mL of ROPIVACAINE 2mg / ml at the posterior capsule, once the surfaces joints prepared to accommodate the prosthesis and by two placebo infiltrations of 50mL each of physiological saline in the medial and lateral ligaments and in the edges of the incision. | Drug | locoregional analgesia by a block on the adductor channel |
| locoregional analgesia by periarticular local infiltrationsA placebo injection to the adductor channel of 20 mL of physiological serum will be performed in the pre-induction room before surgery, according to the same procedures as the patients of the ACB group. During the surgical procedure, patients in the ILA group will receive a total dose of 300mg of ROPIVACAINE 2mg / ml in the form of 3 periarticular injections. The first injection of 50mL of ROPIVACAINE 2mg / ml will be made once the articular surfaces are prepared to receive the prosthesis, at the level of the posterior capsule. The second injection of 50mL of ROPIVACAINE 2mg / ml will be performed once the total knee prosthesis is installed, in the medial and lateral ligaments. Finally, the last injection will also include 50mL of ROPIVACAINE 2mg / ml and will be made in the edges of the incision at the time of closure. | Drug | locoregional analgesia by periarticular local infiltrations |
Primary outcome
the cumulative consumption of MORPHINE
Time frame: during the first 48 hours following the surgical incision
cumulative dose of morphine (miligrams). The administration of morphine will be done using a self-controlled analgesic pump (PCA). It will be made available to the patient when he leaves the block. The PCA allows the patient to adapt his consumption of morphine to his needs in analgesics. A nurse regularly reports the amount of morphine that the patient has administered.
10 secondary outcomes
Pain at rest
Time frame: Resting pain will be measured every 4 hours in the first 24 hours, then every 8 hours between 24 and 72 hours
pain in movement
Time frame: at day 3
quality of the analgesia offered by the ACB
Time frame: within 48 hours after the injection to the adductor channel
quality of the analgesia offered by the ILA
Time frame: within 48 hours after the end of surgery
quality of the analgesia
Time frame: within 48 hours after the surgical incision time
Functional capabilities and rehabilitation
Time frame: at day 3
Duration of hospitalization
Time frame: at day 3
Patient satisfaction
Time frame: at day 3
Secondary complications due to adductor channel block
Time frame: Day 0 : At the time of the ACB in the pre-induction room
Complications secondary to analgesic medications and surgery
Time frame: at day 3
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 3 Oct 2025.
- Results publication: PubMed 36723467Pic C, Macabeo C, Waissi E, Lasselin P, Raffin M, Pradat P, Lalande L, Lustig S, Aubrun F, Dziadzko M. No Benefit of Adductor Canal Block Compared with Anterior Local Infiltration Analgesia in Primary Total Knee Arthroplasty: A Single-Blinded Randomized Controlled Clinical Trial. J Bone Joint Surg Am. 2023 Feb 1;105(3):231-238. doi: 10.2106/JBJS.22.00745. Epub 2022 Nov 18.
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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.
Caroline Macabeo principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing locoregional analgesia by a block on the adductor channel and locoregional analgesia by periarticular local infiltrations in people with Analgesic, run by Hospices Civils de Lyon 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 18 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 3 Oct 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the cumulative consumption of MORPHINE (time frame: during the first 48 hours following the surgical incision). 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 NCT03620136, 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 3 Oct 2025.