NCT07568106

Brief Summary

Total knee arthroplasty is associated with moderate to severe postoperative pain, which may delay mobilization and recovery. Multimodal analgesia including regional anesthesia techniques is widely used to improve outcomes. The adductor canal block (ACB) provides anteromedial knee analgesia but may not adequately cover the posterolateral region. The biceps femoris short head (BiFeS) block is a novel motor-sparing regional anesthesia technique targeting the posterolateral capsule of the knee. This randomized controlled trial aims to compare the analgesic efficacy and functional outcomes of ACB combined with BiFeS block versus ACB alone in patients undergoing total knee arthroplasty. The primary outcome is posterior knee pain at postoperative 6 hours. Secondary outcomes include pain scores within 48 hours, opioid consumption, early and late functional recovery, and opioid-related adverse effects.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started May 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

First Submitted

Initial submission to the registry

April 23, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

April 23, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

Total Knee ArthroplastyAdductor Canal BlockBiceps Femoris Short Head BlockPostoperative PainFunctional RecoveryOpioid ConsumptionKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Posterior Knee Pain Intensity

    Posterior knee pain assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.

    6 hours postoperatively

Secondary Outcomes (7)

  • Postoperative Pain Intensity

    30 minutes, 1, 6, 12, 24, and 48 hours postoperatively

  • Total Opioid Consumption

    0-48 hours postoperatively

  • Rescue Analgesic Use

    0-48 hours postoperatively

  • Functional Recovery

    24 hours, 48 hours, and 6 weeks postoperatively

  • Quadriceps Muscle Strength

    Preoperatively, 24 hours, 48 hours, and 6 weeks postoperatively

  • +2 more secondary outcomes

Study Arms (2)

ACB + BiFeS

EXPERIMENTAL

Participants receive spinal anesthesia followed by an ultrasound-guided adductor canal block and a biceps femoris short head block using local anesthetic for postoperative analgesia.

Procedure: Adductor Canal BlockProcedure: Biceps Femoris Short Head Block

ACB + sham BiFeS

ACTIVE COMPARATOR

Participants receive spinal anesthesia followed by an ultrasound-guided adductor canal block and a sham biceps femoris short head block using normal saline.

Procedure: Adductor Canal BlockProcedure: Sham Biceps Femoris Short Head Block

Interventions

Ultrasound-guided adductor canal block performed with injection of local anesthetic into the adductor canal to block the saphenous nerve and provide postoperative analgesia following total knee arthroplasty.

ACB + BiFeSACB + sham BiFeS

Ultrasound-guided biceps femoris short head block performed with injection of local anesthetic between the biceps femoris short head and femur to target the posterolateral innervation of the knee for postoperative analgesia.

ACB + BiFeS

Sham ultrasound-guided biceps femoris short head block performed with injection of normal saline at the same anatomical location to maintain blinding without providing active analgesia.

ACB + sham BiFeS

Eligibility Criteria

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

You may qualify if:

  • ASA I-III
  • Adult patients undergoing unilateral primary TKA
  • Planned spinal anesthesia
  • Written informed consent

You may not qualify if:

  • Coagulopathy
  • Drug allergy
  • BMI \> 35
  • Renal/hepatic failure
  • Chronic pain or opioid use
  • Depression or psychiatric disorder
  • Revision or bilateral TKA
  • Neurological deficits
  • Preoperative ROM \< 90°

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, Saricam, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Demet Lafli Tunay, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology

Study Record Dates

First Submitted

April 23, 2026

First Posted

May 5, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations