NCT07739108

Brief Summary

This study evaluates the analgesic efficacy and motor-sparing properties of ultrasound-guided Suprainguinal Fascia Iliaca Block (S-FIB) compared with Adductor Canal Block (ACB) in patients undergoing primary total knee arthroplasty (TKA). The main hypothesis is that ACB better preserves quadriceps muscle strength, allowing earlier functional mobilization, while providing comparable (non-inferior) analgesia to S-FIB.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Aug 2026

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

July 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

August 12, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 28, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Suprainguinal Fascia Iliaca Block Adductor Canal Block Ultrasound-Guided Nerve Block Quadriceps Muscle Strength Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Intensity (NRS)

    Numerical Rating Scale (0-10) at rest and during active knee flexion (30°). Time Frame: Postoperative hours 2, 6, 12, 24, and 48.

    Postoperative hours 24 hour

Secondary Outcomes (4)

  • Quadriceps Muscle Strength

    Postoperative hours 6 and 12.

  • Cumulative Opioid Consumption

    24 and 48 hours postoperatively.

  • Time to First Mobilization

    Up to 48 hours postoperatively.

  • Quality of Recovery (QoR-15)

    Baseline (preoperative) and 24 hours postoperatively.

Study Arms (2)

S-FIB

ACTIVE COMPARATOR

Active ultrasound-guided Suprainguinal Fascia Iliaca Block

Drug: PCA

ACB

ACTIVE COMPARATOR

Active ultrasound-guided Adductor Canal Block

Drug: PCA

Interventions

PCADRUG

All patients receive standardized spinal anesthesia and postoperative intravenous PCA tramadol within a standardized multimodal regimen.

ACBS-FIB

Eligibility Criteria

Age45 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA Physical Status I, II, or III
  • Scheduled for elective unilateral primary total knee arthroplasty
  • Able to understand and operate the PCA device
  • Written informed consent provided

You may not qualify if:

  • Pre-existing lower-extremity neurological deficit or motor weakness (e.g., severe diabetic neuropathy)
  • Chronic opioid use (\>30 mg oral morphine equivalents/day for \>3 months)
  • Infection at the block site or systemic sepsis
  • Coagulopathy or bleeding diathesis
  • Allergy to local anesthetics or study medications
  • Revision TKA or bilateral knee procedures
  • Cognitive impairment or inability to perform mobility/pain assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Passive Cutaneous Anaphylaxis

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Officials

  • Korgün Ökmen, PhD.MD

    University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Department of Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.PhD.MD

Study Record Dates

First Submitted

July 28, 2026

First Posted

July 31, 2026

Study Start (Estimated)

August 12, 2026

Primary Completion (Estimated)

August 12, 2027

Study Completion (Estimated)

September 12, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07