Femoral Triangle Block vs Adductor Canal Block on Early Quadriceps Function After Total Knee Arthroplasty

NCT07524387 | Recruiting

• 1 other identifier: DGH-2025-022
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Total Knee Arthroplasty; Total Knee Arthroplasty Recovery; Total Knee Arthroplasty Postoperative Pain

Keywords

Postoperative Pain; Total Knee Arthroplasty; Peripheral Nerve Block; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  6 hours after block completion

Secondary Outcomes (15)

• Participants with quadriceps functional impairment at 24 hours after block completion

  24 hours after block completion

• Participants able to perform a structured straight leg raise at 6 and 24 hours after block completion

  6 and 24 hours after block completion

• Normalized isometric quadriceps muscle strength at 6 and 24 hours after block completion

  6 and 24 hours after block completion

• Postoperative pain intensity at rest on the Numeric Rating Scale

  1, 2, 3, 6, 12, 18, and 24 hours after surgery

• Postoperative pain intensity during active knee movement on the Numeric Rating Scale

  1, 2, 3, 6, 12, 18, and 24 hours after surgery

Study Arms (2)

Femoral Triangle Block (FTB) Group

EXPERIMENTAL

Ultrasound-guided femoral triangle block with standardized multimodal analgesia including popliteal plexus block.

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.

Procedure: Adductor Canal Block (ACB) Group

Interventions

Femoral Triangle Block (FTB) Group PROCEDURE

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.

Femoral Triangle Block (FTB) Group

Adductor Canal Block (ACB) Group PROCEDURE

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.

Adductor Canal Block (ACB) Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Social Medical Corporation Daiyukai: lead

Study Sites (1)

Department of Anesthesiology, Daiyukai General Hospital

Ichinomiya, Aichi-ken, 491-8511, Japan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Norihiro Sakai, MD, PhD

  Department of Anesthesiology, Daiyukai General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norihiro Sakai, MD, PhD

CONTACT

+81-586-72-1211; dykmasui@gmail.com

Tomohiro Michino, MD, PhD

CONTACT

+81-586-72-1211; dykmasui@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, parallel-group trial with two intervention arms (FTB and ACB).

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 13, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)