NCT07803887

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

August 3, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Last Updated

September 4, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

August 3, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Biceps Femoris Short Head BlockAdductor Canal BlockTotal Knee ArthroplastyRegional AnesthesiaKnee OsteoarthritisEnhanced Recovery After Surgery (ERAS)

Outcome Measures

Primary Outcomes (1)

  • Cumulative Opioid Consumption

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

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

Secondary Outcomes (11)

  • Postoperative Pain Intensity

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

  • Time to First Rescue Analgesic Administration

    During the first 48 postoperative hours

  • Quadriceps Muscle Strength

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

  • Functional Mobility

    24 and 48 hours after surgery

  • Knee Range of Motion

    Preoperatively and at 12 and 24 hours after surgery

  • +6 more secondary outcomes

Study Arms (2)

Ultrasound-Guided Adductor Canal Block

ACTIVE COMPARATOR

Participants 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.

Procedure: Ultrasound-Guided Adductor Canal Block

Ultrasound-Guided Adductor Canal Block Combined With Biceps Femoris Short Head Block

EXPERIMENTAL

Participants 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.

Procedure: Ultrasound-Guided Adductor Canal BlockProcedure: Ultrasound-Guided Biceps Femoris Short Head Block

Interventions

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 Adductor Canal BlockUltrasound-Guided Adductor Canal Block Combined With Biceps Femoris Short Head Block

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.

Ultrasound-Guided Adductor Canal Block Combined With Biceps Femoris Short Head Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain, Postoperative

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Serhat Gulersen, MD,

    University of Health Sciences Türkiye, Antalya Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nilgun Kavrut Ozturk, MD,Professor

CONTACT

Serhat Gulersen, MD,

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 3, 2026

First Posted

September 4, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

March 20, 2027

Last Updated

September 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations