Total Knee ArthroplastyNCT07524387
Femoral Triangle Block vs Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty
A study testing Femoral Triangle Block (FTB) Group and Adductor Canal Block (ACB) Group in people with Total Knee Arthroplasty and Total Knee Arthroplasty Recovery, run by Social Medical Corporation Daiyukai at 1 site in Japan.
Trial summary
The goal of this clinical trial is to compare the effects of femoral triangle block (FTB) and adductor canal block (ACB) on early quadriceps function after total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Total Knee Arthroplasty Recovery, Total Knee Arthroplasty Postoperative Pain
- What is being tested?
- Femoral Triangle Block (FTB) Group and Adductor Canal Block (ACB) Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteJapan
- Study dates
- 13 Apr 2026to 31 Mar 2029
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 20 years of age) are scheduled to undergo primary unilateral TKA.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Ability to ambulate independently prior to surgery.
- Ability to understand the study procedures and provide written informed consent.
- Planned perioperative anesthesia management including regional anesthesia as part of standard clinical care.
- Ability to extend the knee below 30 degrees preoperatively (no knee extension contracture)
Who cannot join
- Known allergy or contraindication to local anesthetic agents used in this study.
- Pre-existing neurological or neuromuscular disorders affect lower limb strength or motor control.
- Severe cognitive impairment or psychiatric conditions interfere with study participation or assessment.
- History of revision knee arthroplasty on the operative side.
- Severe preoperative quadriceps weakness that precludes reliable baseline strength assessment.
- Any condition deemed by the investigator to make participation inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Daiyukai General Hospital
Ichinomiya, Aichi-ken, 491-8511
Norihiro Sakai, MD, PhD, +81-586-72-1211, dykmasui@gmail.com
Tomohiro Michino, MD, PhD, +81-586-72-1211, dykmasui@gmail.com
About this study
Official title: Postoperative Effects of Femoral Triangle Block Versus Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty Under a Multimodal Analgesia Protocol: A Randomized Double-Blind Controlled Trial
The goal of this clinical trial is to compare the effects of femoral triangle block (FTB) and adductor canal block (ACB) on early quadriceps function after total knee arthroplasty (TKA).
The main question it aims to answer is whether FTB causes more early quadriceps functional impairment than ACB under a standardized multimodal analgesia protocol.
Read more
Researchers will compare FTB and ACB using a composite binary functional outcome measured 6 hours after block completion. Quadriceps functional impairment is defined as the inability to perform a structured straight leg raise or quadriceps muscle strength <50% of the preoperative baseline.
Participants will be randomly assigned to receive ultrasound-guided FTB or ACB. All participants will also receive a popliteal plexus block and standardized multimodal analgesia.
Read the detailed description
This is a single-center, randomized, parallel-group clinical trial designed to compare the postoperative effects of femoral triangle block (FTB) and adductor canal block (ACB) on early quadriceps function after primary unilateral total knee arthroplasty (TKA). A total of 136 adult participants are planned for enrollment at Daiyukai General Hospital.
Participants will be randomly assigned to receive ultrasound-guided FTB or ultrasound-guided ACB as part of a standardized multimodal analgesia protocol. In all participants, a popliteal plexus block will also be performed to standardize posterior knee analgesia.
The primary outcome is quadriceps functional impairment at 6 hours after block completion, assessed using a composite binary functional outcome defined as the inability to perform a structured straight leg raise or normalized isometric quadriceps muscle strength <50% of the preoperative baseline.
Secondary outcomes include quadriceps functional impairment at 24 hours after block completion using the same composite definition, postoperative pain intensity, rescue analgesic consumption, early mobilization and rehabilitation-related measures, active knee range of motion, time to achieve active knee flexion of at least 120 degrees, and ultrasound-assessed local anesthetic spread.
The study aims to determine whether FTB results in greater early motor impairment than ACB under a standardized multimodal analgesia protocol while maintaining clinically appropriate postoperative analgesia.
- Conditions
- Total Knee Arthroplasty, Total Knee Arthroplasty Recovery, Total Knee Arthroplasty Postoperative Pain
- Being tested
- Femoral Triangle Block (FTB) Group, Adductor Canal Block (ACB) Group
- Keywords
- Postoperative Pain, Total Knee Arthroplasty, Peripheral Nerve Block, Postoperative Recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Triangle Block (FTB) GroupProcedure or surgery
Ultrasound-guided femoral triangle block performed as part of a standardized multimodal analgesia protocol for total knee arthroplasty.
A total of 10 mL of 0.25% levobupivacaine is injected in the femoral triangle to achieve sensory blockade of the saphenous nerve, the nerve to vastus medialis, and surrounding structures.
The injection is performed at the distal femoral triangle under ultrasound guidance, targeting the perineural space adjacent to the relevant nerve branches.
In all participants, a popliteal plexus block using 15 mL of 0.25% levobupivacaine is additionally performed to standardize posterior knee analgesia.
Adductor Canal Block (ACB) GroupProcedure or surgery
Ultrasound-guided adductor canal block performed as part of a standardized multimodal analgesia protocol for total knee arthroplasty.
A total of 10 mL of 0.25% levobupivacaine is administered in a divided manner within the proximal adductor canal, targeting both the saphenous nerve within the canal and the nerve to vastus medialis running adjacent to the canal.
The injection is performed under ultrasound guidance to achieve selective sensory blockade while minimizing motor involvement.
In all participants, a popliteal plexus block using 15 mL of 0.25% levobupivacaine is additionally performed to standardize posterior knee analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Femoral Triangle Block (FTB) Group | Experimental | Ultrasound-guided femoral triangle block with standardized multimodal analgesia including popliteal plexus block. Receives: Procedure: Femoral Triangle Block (FTB) Group |
| Adductor Canal Block (ACB) Group | Active comparator | Ultrasound-guided adductor canal block with standardized multimodal analgesia including popliteal plexus block. Receives: Procedure: Adductor Canal Block (ACB) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with quadriceps functional impairment at 6 hours after block completion
Composite binary functional outcome defined as the inability to perform a structured straight leg raise (SLR) or normalized isometric quadriceps muscle strength <50% of the preoperative baseline. The outcome will be reported as the percentage of participants with quadriceps functional impairment.
Measured: 6 hours after block completion
Secondary outcomes (15)
Participants with quadriceps functional impairment at 24 hours after block completion
Composite binary functional outcome defined as the inability to perform a structured SLR or normalized isometric quadriceps muscle strength <50% of the preoperative baseline. The outcome will be reported as the percentage of participants with quadriceps functional impairment.
Measured: 24 hours after block completion
Participants able to perform a structured straight leg raise at 6 and 24 hours after block completion
Ability to perform a structured straight leg raise (SLR), assessed using the predefined study procedure. The outcome will be reported as the percentage of participants able to perform the structured SLR.
Measured: 6 and 24 hours after block completion
Normalized isometric quadriceps muscle strength at 6 and 24 hours after block completion
Normalized isometric quadriceps muscle strength, expressed as a percentage of the preoperative baseline (%MVIC). Higher values indicate greater preservation of quadriceps strength.
Measured: 6 and 24 hours after block completion
Postoperative pain intensity at rest on the Numeric Rating Scale
Pain intensity at rest assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable; higher scores indicate worse pain. Pain will be assessed postoperatively after patient awakening.
Measured: 1, 2, 3, 6, 12, 18, and 24 hours after surgery
Postoperative pain intensity during active knee movement on the Numeric Rating Scale
Pain intensity during active knee movement assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable; higher scores indicate worse pain. Pain will be assessed postoperatively after patient awakening.
Measured: 1, 2, 3, 6, 12, 18, and 24 hours after surgery
Participants requiring any rescue analgesic during the first 24 postoperative hours
Proportion of participants who receive at least one rescue analgesic during the first 24 postoperative hours. Rescue analgesia is permitted when the Numeric Rating Scale (NRS) pain score is 5 or higher or when the participant requests additional analgesia. Allowed rescue analgesics include loxoprofen, acetaminophen, diclofenac suppository, and intramuscular pentazocine. The choice of rescue agent is left to the treating clinical team, and no fixed sequence of rescue analgesics is mandated.
Measured: Within the first postoperative 24 hours
Number of rescue analgesic administrations during the first 48 postoperative hours
Total number of rescue analgesic administrations per participant during the first 48 postoperative hours.
Rescue analgesia is permitted when the Numeric Rating Scale (NRS) pain score is 5 or higher or when the participant requests additional analgesia. Allowed rescue analgesics include loxoprofen, acetaminophen, diclofenac suppository, and intramuscular pentazocine. The choice of rescue agent is left to the treating clinical team, and no fixed sequence of rescue analgesics is mandated.
Measured: Within the first postoperative 48 hours
Time to first mobilization
Time from block completion to the first documented mobilization attempt.
Measured: Within 24 hours after block completion
Ability to stand during the first postoperative rehabilitation session
Proportion of participants able to complete supported standing during the first routine postoperative rehabilitation session, as assessed and documented by a physical therapist.
Measured: Postoperative day 1
Walking distance during routine postoperative rehabilitation
Distance ambulated in meters during supervised postoperative rehabilitation sessions, as assessed and documented by a physical therapist.
Measured: From postoperative days 1 to 7
Active knee flexion angle of the operated knee
Active knee flexion angle of the operated knee, measured in degrees by rehabilitation staff using a goniometer during routine postoperative rehabilitation assessment. Higher values indicate greater knee flexion.
Measured: Postoperative days 1, 2, 3, and 7
Active knee extension deficit angle of the operated knee
Active knee extension deficit angle of the operated knee, measured in degrees by rehabilitation staff using a goniometer during routine postoperative rehabilitation assessment, where 0 degrees indicates full knee extension and higher values indicate greater residual extension limitation.
Measured: Postoperative days 1, 2, 3, and 7
Time to achieve active knee flexion of at least 120 degrees
Number of days required to achieve active knee flexion of the operated knee of at least 120 degrees, based on routine postoperative rehabilitation assessment by rehabilitation staff using a goniometer.
Measured: Up to postoperative day 7
Cranial spread of local anesthetic from the injection point
Cranial spread of local anesthetic from the injection point, measured in centimeters on ultrasound immediately after block completion. Higher values indicate greater cranial spread of the injectate.
Measured: Immediately after block completion
Caudal spread of local anesthetic from the injection point
Caudal spread of local anesthetic from the injection point, measured in centimeters on ultrasound immediately after block completion. Higher values indicate greater caudal spread of the injectate.
Measured: Immediately after block completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start13 Apr 2026
- Primary completion15 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Model description
- Randomized, double-blind, parallel-group trial with two intervention arms (FTB and ACB).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Social Medical Corporation Daiyukai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norihiro Sakai, MD, PhD, Principal investigator, Department of Anesthesiology, Daiyukai General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524387
- Sponsor's protocol ID
- DGH-2025-022
- Status last verified
- Apr 2026
- First submitted
- 29 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Effects of Femoral Triangle Block Versus Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty Under a Multimodal Analgesia Protocol: A Randomized Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07524387
- Acronym / sponsor ID
- DGH-2025-022
- Conditions
- Total Knee Arthroplasty, Total Knee Arthroplasty Recovery, Total Knee Arthroplasty Postoperative Pain
- Keywords
- Postoperative Pain, Total Knee Arthroplasty, Peripheral Nerve Block, Postoperative Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Social Medical Corporation DaiyukaiUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 13 Apr 2026 (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 goal of this clinical trial is to compare the effects of femoral triangle block (FTB) and adductor canal block (ACB) on early quadriceps function after total knee arthroplasty (TKA).
The main question it aims to answer is whether FTB causes more early quadriceps functional impairment than ACB under a standardized multimodal analgesia protocol.
Researchers will compare FTB and ACB using a composite binary functional outcome measured 6 hours after block completion. Quadriceps functional impairment is defined as the inability to perform a structured straight leg raise or quadriceps muscle strength <50% of the preoperative baseline.
Participants will be randomly assigned to receive ultrasound-guided FTB or ACB. All participants will also receive a popliteal plexus block and standardized multimodal analgesia.
Detailed description
This is a single-center, randomized, parallel-group clinical trial designed to compare the postoperative effects of femoral triangle block (FTB) and adductor canal block (ACB) on early quadriceps function after primary unilateral total knee arthroplasty (TKA). A total of 136 adult participants are planned for enrollment at Daiyukai General Hospital.
Participants will be randomly assigned to receive ultrasound-guided FTB or ultrasound-guided ACB as part of a standardized multimodal analgesia protocol. In all participants, a popliteal plexus block will also be performed to standardize posterior knee analgesia.
The primary outcome is quadriceps functional impairment at 6 hours after block completion, assessed using a composite binary functional outcome defined as the inability to perform a structured straight leg raise or normalized isometric quadriceps muscle strength <50% of the preoperative baseline.
Secondary outcomes include quadriceps functional impairment at 24 hours after block completion using the same composite definition, postoperative pain intensity, rescue analgesic consumption, early mobilization and rehabilitation-related measures, active knee range of motion, time to achieve active knee flexion of at least 120 degrees, and ultrasound-assessed local anesthetic spread.
The study aims to determine whether FTB results in greater early motor impairment than ACB under a standardized multimodal analgesia protocol while maintaining clinically appropriate postoperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, parallel-group trial with two intervention arms (FTB and ACB).
| Arm | Type | Receives |
|---|---|---|
| Femoral Triangle Block (FTB) Group | Experimental | Procedure: Femoral Triangle Block (FTB) GroupUltrasound-guided femoral triangle block with standardized multimodal analgesia including popliteal plexus block. |
| Adductor Canal Block (ACB) Group | Active comparator | Procedure: Adductor Canal Block (ACB) GroupUltrasound-guided adductor canal block with standardized multimodal analgesia including popliteal plexus block. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (≥ 20 years of age) are scheduled to undergo primary unilateral TKA.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Ability to ambulate independently prior to surgery.
- Ability to understand the study procedures and provide written informed consent.
- Planned perioperative anesthesia management including regional anesthesia as part of standard clinical care.
Key exclusion criteria (6 listed)
- Known allergy or contraindication to local anesthetic agents used in this study.
- Pre-existing neurological or neuromuscular disorders affect lower limb strength or motor control.
- Severe cognitive impairment or psychiatric conditions interfere with study participation or assessment.
- History of revision knee arthroplasty on the operative side.
- Severe preoperative quadriceps weakness that precludes reliable baseline strength assessment.
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 |
|---|---|---|
| Femoral Triangle Block (FTB) GroupUltrasound-guided femoral triangle block performed as part of a standardized multimodal analgesia protocol for total knee arthroplasty. A total of 10 mL of 0.25% levobupivacaine is injected in the femoral triangle to achieve sensory blockade of the saphenous nerve, the nerve to vastus medialis, and surrounding structures. The injection is performed at the distal femoral triangle under ultrasound guidance, targeting the perineural space adjacent to the relevant nerve branches. In all participants, a popliteal plexus block using 15 mL of 0.25% levobupivacaine is additionally performed to standardize posterior knee analgesia. | Procedure or surgery | Femoral Triangle Block (FTB) Group |
| Adductor Canal Block (ACB) GroupUltrasound-guided adductor canal block performed as part of a standardized multimodal analgesia protocol for total knee arthroplasty. A total of 10 mL of 0.25% levobupivacaine is administered in a divided manner within the proximal adductor canal, targeting both the saphenous nerve within the canal and the nerve to vastus medialis running adjacent to the canal. The injection is performed under ultrasound guidance to achieve selective sensory blockade while minimizing motor involvement. In all participants, a popliteal plexus block using 15 mL of 0.25% levobupivacaine is additionally performed to standardize posterior knee analgesia. | Procedure or surgery | Adductor Canal Block (ACB) Group |
Primary outcome
Participants with quadriceps functional impairment at 6 hours after block completion
Time frame: 6 hours after block completion
Composite binary functional outcome defined as the inability to perform a structured straight leg raise (SLR) or normalized isometric quadriceps muscle strength <50% of the preoperative baseline. The outcome will be reported as the percentage of participants with quadriceps functional impairment.
15 secondary outcomes
Participants with quadriceps functional impairment at 24 hours after block completion
Time frame: 24 hours after block completion
Participants able to perform a structured straight leg raise at 6 and 24 hours after block completion
Time frame: 6 and 24 hours after block completion
Normalized isometric quadriceps muscle strength at 6 and 24 hours after block completion
Time frame: 6 and 24 hours after block completion
Postoperative pain intensity at rest on the Numeric Rating Scale
Time frame: 1, 2, 3, 6, 12, 18, and 24 hours after surgery
Postoperative pain intensity during active knee movement on the Numeric Rating Scale
Time frame: 1, 2, 3, 6, 12, 18, and 24 hours after surgery
Participants requiring any rescue analgesic during the first 24 postoperative hours
Time frame: Within the first postoperative 24 hours
Number of rescue analgesic administrations during the first 48 postoperative hours
Time frame: Within the first postoperative 48 hours
Time to first mobilization
Time frame: Within 24 hours after block completion
Ability to stand during the first postoperative rehabilitation session
Time frame: Postoperative day 1
Walking distance during routine postoperative rehabilitation
Time frame: From postoperative days 1 to 7
Active knee flexion angle of the operated knee
Time frame: Postoperative days 1, 2, 3, and 7
Active knee extension deficit angle of the operated knee
Time frame: Postoperative days 1, 2, 3, and 7
Time to achieve active knee flexion of at least 120 degrees
Time frame: Up to postoperative day 7
Cranial spread of local anesthetic from the injection point
Time frame: Immediately after block completion
Caudal spread of local anesthetic from the injection point
Time frame: Immediately after block completion
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 16 Apr 2026.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data available to other researchers.
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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.
Norihiro Sakai, MD, PhD principal investigator
Department of Anesthesiology, Daiyukai General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Triangle Block (FTB) Group and Adductor Canal Block (ACB) Group in people with Total Knee Arthroplasty and Total Knee Arthroplasty Recovery, run by Social Medical Corporation Daiyukai at 1 site in Japan.
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 6 inclusion and 6 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 16 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 Japan. 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 Norihiro Sakai, MD, PhD (+81-586-72-1211, dykmasui@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with quadriceps functional impairment at 6 hours after block completion (time frame: 6 hours after block completion). 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 16 Apr 2026.