Osteo Arthritis KneeNCT05487053
The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement
A study testing Single-shot adductor canal block and Continuous femoral nerve block in people with Osteo Arthritis Knee and Gonarthrosis, run by Negovsky Reanimatology Research Institute at 1 site in Russia.
Trial summary
Total knee replacement (TKR) is considered the most effective and safe method of radical treatment of late stages of knee osteoarthritis. A well-known problem of TKR is a severe postoperative pain syndrome, which is observed in more than 50% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Gonarthrosis
- What is being tested?
- Single-shot adductor canal block and Continuous femoral nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteRussia
- Study dates
- 3 Feb 2024to 1 Jul 2028
- 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
- Age ≥ 18
- Planned primary total knee replacement
- Planned neuraxial anesthesia
- Written informed consent
Who cannot join
- Urgent surgery
- Planned revision total knee replacement
- Known allergic reaction to anesthetics
- Confirmed localized infection at the puncture sites
- Confirmed localized tumor at the puncture sites
- Peripheral neuropathy of the lower extremities
- Parkinson's disease
- Previously enrolled in this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Clinical Hospital on Yauza
Moscow, 111033
Levan Berikashvili, PhD, +79263308968, lb.berikashvili@gmail.com
Levan Berikashvili, PhD
About this study
Official title: The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement (AdORe - ACB)
Total knee replacement (TKR) is considered the most effective and safe method of radical treatment of late stages of knee osteoarthritis. A well-known problem of TKR is a severe postoperative pain syndrome, which is observed in more than 50% of patients.
Femoral nerve block (FNB) is the "gold standard" for continuous postoperative analgesia after total knee replacement, as it is effective in reducing the frequency of use of opioid analgetics and reduce the duration of hospitalization. At the same time, the negative effect of this method is the motor blockade of the quadriceps femoris muscle which leads to functional impairment and is associated with an increased risk of falling.
Read more
Adductor canal block (ACB) provides adequate analgesia comparable to femoral nerve block. Moreover, ACB doesn't affect the motor function of the quadriceps femoris muscle.
The possibility of enhanced recovery after total knee replacement is the reason to compare single-shot adductor canal block and continuous femoral nerve block.
- Conditions
- Osteo Arthritis Knee, Gonarthrosis
- Being tested
- Single-shot adductor canal block, Continuous femoral nerve block
- Keywords
- Osteo Arthritis Knee, Gonarthrosis, Regional anesthesia, Analgesia, Postoperative analgesia, Total knee replacement, Continuous femoral nerve block, Femoral nerve block, Continuous adductor canal block, Adductor canal block
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-shot adductor canal blockProcedure or surgery
Postoperative analgesia in this group will be carried out by a single-shot bolus of 20 ml Ropivacaine 0.5% in the region of the middle third of the adductor canal.
Continuous femoral nerve blockProcedure or surgery
Postoperative analgesia in this group will be carried out by continuous infusion of local anesthetics through a catheter installed to the femoral nerve in the area of the femoral triangle. Ropivacaine 0.2% solution will be used for postoperative analgesia. Local anesthetic infusion rate is 4 ml/h to 10 ml/h.
| Study group | Role | What they receive |
|---|---|---|
| Single-shot adductor canal block | Experimental | Not described Receives: Procedure: Single-shot adductor canal block |
| Continuous femoral nerve block | Active comparator | Not described Receives: Procedure: Continuous femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation distance
Less meters means worse outcome
Measured: postoperative day 1
Secondary outcomes (11)
Ambulation distance
Less meters means worse outcome
Measured: postoperative day 2
Timed up and go test
More seconds means worse outcome
Measured: postoperative day 1
Timed up and go test
More seconds means worse outcome
Measured: postoperative day 2
10 meters walk test
More seconds means worse outcome
Measured: postoperative day 1
10 meters walk test
More seconds means worse outcome
Measured: postoperative day 2
30 seconds chair stand test
Less exercise done means worse outcome
Measured: postoperative day 1
30 seconds chair stand test
Less exercise done means worse outcome
Measured: postoperative day 2
5 times sit to stand test
More seconds means worse outcome
Measured: postoperative day 1
5 times sit to stand test
More seconds means worse outcome
Measured: postoperative day 2
time to readiness to dicharge
time from the day of surgery to the day of readiness to discharge
Measured: 30 day
length of hospitalization
time from the day of surgery to the day of discharge
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start3 Feb 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Negovsky Reanimatology Research Institute
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Valery Likhvantsev, MD, Negovsky Reanimatology Research Institute
- Investigators
- Valery Likhvantsev, Principal investigator, Negovsky Reanimatology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487053
- Sponsor's protocol ID
- AdORe - ACB
- Status last verified
- Apr 2026
- First submitted
- 3 Aug 2022
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Single-shot Adductor Canal Block Versus Continuous Femoral Nerve Block on Rehabilitation After Total Knee Replacement (AdORe - ACB)
- ClinicalTrials.gov ID
- NCT05487053
- Acronym / sponsor ID
- AdORe - ACB
- Conditions
- Osteo Arthritis Knee, Gonarthrosis
- Keywords
- Osteo Arthritis Knee, Gonarthrosis, Regional anesthesia, Analgesia, Postoperative analgesia, Total knee replacement, Continuous femoral nerve block, Femoral nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Negovsky Reanimatology Research InstituteOther government
- Study start
- 3 Feb 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 4 Aug 2022 (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.
Total knee replacement (TKR) is considered the most effective and safe method of radical treatment of late stages of knee osteoarthritis. A well-known problem of TKR is a severe postoperative pain syndrome, which is observed in more than 50% of patients.
Femoral nerve block (FNB) is the "gold standard" for continuous postoperative analgesia after total knee replacement, as it is effective in reducing the frequency of use of opioid analgetics and reduce the duration of hospitalization. At the same time, the negative effect of this method is the motor blockade of the quadriceps femoris muscle which leads to functional impairment and is associated with an increased risk of falling.
Adductor canal block (ACB) provides adequate analgesia comparable to femoral nerve block. Moreover, ACB doesn't affect the motor function of the quadriceps femoris muscle.
The possibility of enhanced recovery after total knee replacement is the reason to compare single-shot adductor canal block and continuous femoral nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-shot adductor canal block | Experimental | Procedure: Single-shot adductor canal block |
| Continuous femoral nerve block | Active comparator | Procedure: Continuous femoral nerve 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)
- Age ≥ 18
- Planned primary total knee replacement
- Planned neuraxial anesthesia
- Written informed consent
Key exclusion criteria (8 listed)
- Urgent surgery
- Planned revision total knee replacement
- Known allergic reaction to anesthetics
- Confirmed localized infection at the puncture sites
- Confirmed localized tumor at the puncture sites
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 |
|---|---|---|
| Single-shot adductor canal blockPostoperative analgesia in this group will be carried out by a single-shot bolus of 20 ml Ropivacaine 0.5% in the region of the middle third of the adductor canal. | Procedure or surgery | Single-shot adductor canal block |
| Continuous femoral nerve blockPostoperative analgesia in this group will be carried out by continuous infusion of local anesthetics through a catheter installed to the femoral nerve in the area of the femoral triangle. Ropivacaine 0.2% solution will be used for postoperative analgesia. Local anesthetic infusion rate is 4 ml/h to 10 ml/h. | Procedure or surgery | Continuous femoral nerve block |
Primary outcome
Ambulation distance
Time frame: postoperative day 1
Less meters means worse outcome
11 secondary outcomes
Ambulation distance
Time frame: postoperative day 2
Timed up and go test
Time frame: postoperative day 1
Timed up and go test
Time frame: postoperative day 2
10 meters walk test
Time frame: postoperative day 1
10 meters walk test
Time frame: postoperative day 2
30 seconds chair stand test
Time frame: postoperative day 1
30 seconds chair stand test
Time frame: postoperative day 2
5 times sit to stand test
Time frame: postoperative day 1
5 times sit to stand test
Time frame: postoperative day 2
time to readiness to dicharge
Time frame: 30 day
length of hospitalization
Time frame: 30 day
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 15 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.
Valery Likhvantsev principal investigator
Negovsky Reanimatology Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-shot adductor canal block and Continuous femoral nerve block in people with Osteo Arthritis Knee and Gonarthrosis, run by Negovsky Reanimatology Research Institute at 1 site in Russia.
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 15 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 Russia. 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?
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?
Contact Valery Likhvantsev (+79036235982, lik0704@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulation distance (time frame: postoperative day 1). 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 15 Apr 2026.