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Knee Osteoarthritis (OA)BiFeS-TKANCT07803887

Effect of Adding a Biceps Femoris Short Head Block to Adductor Canal Block for Analgesia After Total Knee Arthroplasty

A study testing Ultrasound-Guided Adductor Canal Block and Ultrasound-Guided Biceps Femoris Short Head Block in people with Knee Osteoarthritis (OA) and Postoperative Pain, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Total knee arthroplasty (TKA) is frequently associated with moderate to severe postoperative pain, which may delay mobilization, increase opioid consumption, and impair functional recovery. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Knee Osteoarthritis (OA), Postoperative Pain
What is being tested?
Ultrasound-Guided Adductor Canal Block and Ultrasound-Guided Biceps Femoris Short Head Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2026to 20 Mar 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for elective primary unilateral total knee arthroplasty under spinal -anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) <40 kg/m².
  • Ability to understand the study procedures and provide written informed consent.

Who cannot join

  • Refusal to participate or inability to provide informed consent.
  • Body mass index 40 kg/m2 or higher.
  • ASA physical status IV or V.
  • Known allergy or hypersensitivity to local anesthetics, opioids, or other study -medications.
  • Pregnancy or breastfeeding.
  • Uncontrolled psychiatric disease or severe anxiety interfering with study participation.
Show all 12Show fewer
  • Pre-existing neuromuscular disease or peripheral neuropathy involving the operative limb.
  • Chronic opioid use or opioid dependence.
  • Chronic pain syndrome requiring regular analgesic therapy.
  • Severe hepatic or renal insufficiency.
  • Contraindications to spinal anesthesia or peripheral nerve block, including -coagulopathy, thrombocytopenia, local infection at the injection site, or patient refusal.
  • Planned bilateral or revision total knee arthroplasty.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nilgun Kavrut Ozturk, MD,Professor contact

+905334196049

kavrut@yahoo.com

Serhat Gulersen, MD, contact

+905445336784

serhatgulersen@gmail.com

Turkey (Türkiye)1 site
  • Antalya Training and Research Hospital

    Antalya, Antalya, 07100

    Nilgun Kavrut Ozturk, MD, Professor, +95334196049, kavrut@yahoo.com

    Serhat Gulersen, MD, +905445336784, serhatgulersen@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Analgesic Efficacy of Adding a Short Head of the Biceps Femoris Muscle Block to the Adductor Canal Block in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial

Total knee arthroplasty (TKA) is frequently associated with moderate to severe postoperative pain, which may delay mobilization, increase opioid consumption, and impair functional recovery. Ultrasound-guided adductor canal block (ACB) is widely used as part of multimodal analgesia because it provides effective analgesia while preserving quadriceps muscle strength. However, ACB alone may provide insufficient analgesia for the posterior aspect of the knee. The biceps femoris short head (BiFeS) block is a novel ultrasound-guided regional anesthesia technique targeting the posterolateral sensory innervation of the knee and may enhance postoperative analgesia when combined with ACB. However, clinical evidence regarding its analgesic efficacy in patients undergoing total knee arthroplasty remains limited. This prospective, randomized, controlled trial aims to compare postoperative analgesia between ultrasound-guided adductor canal block alone and adductor canal block combined with a biceps femoris short head block in adult patients undergoing primary total knee arthroplasty under spinal anesthesia. Participants will be randomly assigned in a 1:1 ratio to receive either ACB alone or combined ACB plus BiFeS block. The primary outcome is cumulative opioid consumption during the first 48 postoperative hours. Secondary outcomes include postoperative pain intensity, time to first analgesic request, quadriceps muscle strength, functional recovery, postoperative recovery quality, postoperative nausea and vomiting, patient and surgeon satisfaction, length of hospital stay, and block-related complications.

Read the detailed description

Background

Total knee arthroplasty (TKA) is the definitive surgical treatment for end-stage knee osteoarthritis and is one of the most frequently performed orthopedic procedures worldwide. Despite advances in multimodal analgesic strategies, postoperative pain following TKA remains a major clinical challenge. Inadequate pain control may delay early mobilization, impair functional recovery, prolong hospitalization, increase opioid consumption, and reduce patient satisfaction. Therefore, optimization of regional anesthesia techniques continues to be an important component of enhanced recovery protocols after TKA.

Ultrasound-guided adductor canal block (ACB) has become a widely accepted motor-sparing regional analgesic technique for TKA because it provides effective analgesia to the anteromedial aspect of the knee while largely preserving quadriceps muscle strength. Nevertheless, the posterior compartment of the knee receives sensory innervation from branches of the sciatic nerve that are not consistently anesthetized by ACB alone. Consequently, residual posterior knee pain remains a common limitation of this technique.

The ultrasound-guided biceps femoris short head (BiFeS) block is a recently described regional anesthesia technique that targets the posterolateral sensory innervation of the knee through deposition of local anesthetic within the fascial plane adjacent to the short head of the biceps femoris muscle. Anatomical and preliminary clinical investigations suggest that this technique may provide additional analgesic coverage of the posterior knee while preserving motor function. However, evidence regarding its clinical efficacy as an adjunct to ACB in patients undergoing primary TKA remains limited.

Study Objectives

The objective of this study is to determine whether the addition of an ultrasound-guided BiFeS block to a standard ultrasound-guided ACB provides superior postoperative analgesia compared with ultrasound-guided ACB alone in patients undergoing primary unilateral TKA under spinal anesthesia.

Study Design

This is a prospective, single-center, parallel-group, randomized controlled clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either an ultrasound-guided adductor canal block or an ultrasound-guided adductor canal block combined with a biceps femoris short head block before surgery. All patients underwent total knee arthroplasty under single-shot spinal anesthesia with 15 mg of hyperbaric bupivacaine. No periarticular local infiltration analgesia was performed by the surgical team. Postoperatively, all patients received a standardized multimodal analgesic regimen consisting of intravenous paracetamol (1 g) administered every 8 hours. Rescue analgesia consisted of intravenous tramadol (100 mg), which was administered when the Numeric Rating Scale (NRS) pain score was ≥4.

Outcome Assessment

The primary endpoint is cumulative intravenous morphine consumption (mg) from arrival in the post-anesthesia care unit until 48 hours after surgery. Secondary endpoints include postoperative pain intensity assessed using the Numeric Rating Scale (NRS), time to first rescue analgesic administration, quadriceps muscle strength, functional recovery assessed by the Timed Up and Go test and knee range of motion, quality of postoperative recovery (QoR-15), postoperative nausea and vomiting, patient and surgeon satisfaction, length of hospital stay, and block-related adverse events.

Clinical Significance

This study is designed to provide high-quality evidence regarding the potential clinical benefit of incorporating the BiFeS block into contemporary multimodal analgesic protocols for total knee arthroplasty. If the combined regional analgesic approach demonstrates improved postoperative analgesia while preserving motor function, it may represent an effective strategy to facilitate enhanced recovery after surgery and reduce perioperative opioid requirements.

Being tested
Ultrasound-Guided Adductor Canal Block, Ultrasound-Guided Biceps Femoris Short Head Block
Keywords
Biceps Femoris Short Head Block, Adductor Canal Block, Total Knee Arthroplasty, Regional Anesthesia, Knee Osteoarthritis, Enhanced Recovery After Surgery (ERAS)
Medical subject headings
Osteoarthritis, Knee, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-Guided Adductor Canal BlockProcedure or surgery

    An ultrasound-guided adductor canal block will be performed before the induction of spinal anesthesia using a standardized technique. Following ultrasound identification of the adductor canal, 30 mL of 0.25% bupivacaine will be injected into the adductor canal adjacent to the femoral artery to provide perioperative analgesia for primary unilateral total knee arthroplasty.

  • Ultrasound-Guided Biceps Femoris Short Head BlockProcedure or surgery

    An ultrasound-guided biceps femoris short head block will be performed before the induction of spinal anesthesia using a standardized technique. Following ultrasound identification of the fascial plane adjacent to the short head of the biceps femoris muscle, 20 mL of 0.25% bupivacaine will be administered to provide additional posterolateral knee analgesia as an adjunct to the adductor canal block.

Study groups in NCT07803887
Study groupRoleWhat they receive
Ultrasound-Guided Adductor Canal BlockActive comparatorParticipants assigned to this arm will receive an ultrasound-guided adductor canal block before the induction of spinal anesthesia for primary unilateral total knee arthroplasty. All regional blocks will be performed according to a standardized study protocol. Perioperative anesthetic management, surgical procedures, and postoperative multimodal analgesia will be standardized for all participants.
Receives: Procedure: Ultrasound-Guided Adductor Canal Block
Ultrasound-Guided Adductor Canal Block Combined With Biceps Femoris Short Head BlockExperimentalParticipants assigned to this arm will receive an ultrasound-guided adductor canal block combined with an ultrasound-guided biceps femoris short head block before spinal anesthesia for primary unilateral total knee arthroplasty. Both regional blocks will be performed according to a standardized study protocol. Perioperative anesthetic management, surgical procedures, and postoperative multimodal analgesic regimens will be standardized for all participants.
Receives: Procedure: Ultrasound-Guided Adductor Canal Block; Procedure: Ultrasound-Guided Biceps Femoris Short Head Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Opioid Consumption

    Cumulative opioid consumption during the first 48 postoperative hours, recorded as intravenous morphine equivalent dose (mg).

    Measured: From arrival in the post-anesthesia care unit until 48 hours after surgery

Secondary outcomes (11)
  1. Postoperative Pain Intensity

    Postoperative pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain will be evaluated both at rest and during knee flexion. Lower scores indicate better postoperative analgesia.

    Measured: 4, 8, 12, 24, and 48 hours after surgery

  2. Time to First Rescue Analgesic Administration

    Time from completion of surgery to the first administration of rescue analgesic medication, recorded in hours. Longer time intervals indicate prolonged postoperative analgesic effectiveness.

    Measured: During the first 48 postoperative hours

  3. Quadriceps Muscle Strength

    Quadriceps muscle strength will be assessed using the Manual Muscle Testing (MMT) Scale, ranging from 0 to 5, where 0 represents no visible muscle contraction and 5 represents normal muscle strength against full resistance. Higher scores indicate greater quadriceps muscle strength.

    Measured: Preoperatively and at 8, 24, and 48 hours after surgery

  4. Functional Mobility

    Functional mobility will be evaluated using the Timed Up and Go (TUG) Test. The total time (seconds) required to stand from a seated position, walk 3 meters, turn, return, and sit down will be recorded. Shorter completion times indicate better functional mobility. Participants who were unable to perform the TUG test independently at 24 hours after surgery were withdrawn from the study according to the study protocol.

    Measured: 24 and 48 hours after surgery

  5. Knee Range of Motion

    Active knee flexion range of motion will be measured in the supine position using a standard goniometer. The maximum active knee flexion angle will be recorded in degrees.

    Measured: Preoperatively and at 12 and 24 hours after surgery

  6. Quality of Recovery at 24 Hours Assessed Using QoR-15

    Recovery quality will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire. Total scores range from 0 to 150, with higher scores indicating better postoperative recovery.

    Measured: 24 hours after surgery

  7. Postoperative Nausea and Vomiting

    The severity of postoperative nausea and vomiting will be assessed using a 4-point ordinal scale (0-3), where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Lower scores indicate fewer postoperative symptoms.

    Measured: Incidence of postopereative nausea and/ or vomiting within 48 hours

  8. Patient Satisfaction

    Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater patient satisfaction.

    Measured: 48 hours after surgery

  9. Surgeon Satisfaction

    Surgeon satisfaction with perioperative conditions will be assessed using a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater surgeon satisfaction.

    Measured: At completion of surgery

  10. Length of Hospital Stay

    Length of hospital stay will be defined as the time from completion of surgery until hospital discharge and will be recorded in hours. Shorter hospital stay indicates earlier postoperative recovery.

    Measured: From end of surgery to hospital discharge, assessed up to 10 days

  11. Block-Related Adverse Events

    The incidence of block-related adverse events, including neurological injury, foot drop, local anesthetic systemic toxicity, hematoma, infection, allergic reactions, and myotoxicity, will be recorded. Outcomes will be reported as the number of participants experiencing each event.

    Measured: From block placement to hospital discharge, assessed up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Mar 2027 (estimated)

Resources

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
Eligible participants will be randomly allocated in a 1:1 ratio to receive either ultrasound-guided adductor canal block alone or ultrasound-guided adductor canal block combined with biceps femoris short head block. Postoperative outcomes will be assessed by an investigator blinded to group allocation.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07803887
Sponsor's protocol ID
10840098-202.3.02-446
Acronym
BiFeS-TKA
Status last verified
Jul 2026
First submitted
3 Aug 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-Guided Adductor Canal Block and Ultrasound-Guided Biceps Femoris Short Head Block in people with Knee Osteoarthritis (OA) and Postoperative Pain, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

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 12 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: opening soon, as of the sponsor's last update on 4 Sep 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 Turkey (Türkiye). 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 Nilgun Kavrut Ozturk, MD,Professor (+905334196049, kavrut@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Opioid Consumption (time frame: From arrival in the post-anesthesia care unit until 48 hours after surgery). 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 4 Sep 2026.

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