NCT07577869

Brief Summary

This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided Biceps Femoris Short Head (BiFeS) block combined with adductor canal block on postoperative opioid consumption and pain control in patients undergoing elective total knee arthroplasty under spinal anesthesia. A total of 60 patients aged 18-80 years with ASA physical status I-III scheduled for unilateral elective total knee arthroplasty will be randomized into two groups. The intervention group will receive spinal anesthesia followed by BiFeS block and adductor canal block before surgery, in addition to standard multimodal analgesia and postoperative morphine patient-controlled analgesia (PCA). The control group will receive spinal anesthesia and standard multimodal analgesia with postoperative morphine PCA without peripheral nerve block. The primary outcome is total morphine consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores assessed by Numeric Rating Scale (NRS), time to first analgesic requirement, time to first foot movement, and Quality of Recovery-15 (QoR-15) scores.

Trial Health

63
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 Jun 2026

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

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

June 2, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

May 5, 2026

Last Update Submit

May 9, 2026

Conditions

Keywords

Postoperative PainBiFeSBiFeS and Adductor Canal Block

Outcome Measures

Primary Outcomes (1)

  • Total Morphine Consumption in 24 Hours

    Total cumulative morphine consumption measured from patient-controlled analgesia device during the first 24 postoperative hours.

    Within the first 24 hours after surgery

Secondary Outcomes (4)

  • Numeric Rating Scale (NRS) Pain Scores

    Postoperative 1, 6, 12, and 24 hours

  • Time to First Analgesic Requirement

    24 hours

  • Time to First Foot Movement

    24 hours

  • QoR-15 Score

    24 hours postoperatively

Study Arms (2)

Block Group

EXPERIMENTAL

Patients receive spinal anesthesia followed by ultrasound-guided BiFeS block and adductor canal block before surgery, plus standard multimodal analgesia and morphine PCA.

Procedure: Procedure: Biceps Femoris Short Head Block

Multimodal Analgesia Group

ACTIVE COMPARATOR

Patients receive spinal anesthesia only, followed by standard multimodal analgesia and morphine PCA.

Procedure: Procedure: Spinal Anesthesia

Interventions

Patients will receive spinal anesthesia followed by ultrasound-guided Biceps Femoris Short Head (BiFeS) block using 25 mL of 0.25% bupivacaine and adductor canal block using 15 mL of 0.25% bupivacaine before surgery. Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours.

Also known as: Procedure: Adductor Canal Block, Drug: Morphine PCA, Drug: Paracetamol, Drug: Dexketoprofen, Drug: Fentanyl
Block Group

Patients will receive spinal anesthesia without peripheral nerve block. Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours.

Also known as: Drug: Morphine PCA, Drug: Paracetamol, Drug: Dexketoprofen, Drug:Fentanyl
Multimodal Analgesia Group

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 and older
  • ASA I-III
  • Patients scheduled for elective unilateral knee replacement
  • Eligibility for and consent to spinal anesthesia

You may not qualify if:

  • History of allergy or anaphylaxis to local anesthetics, animal gelatin, or chlorhexidine
  • Bleeding diathesis/inability to discontinue anticoagulants
  • Infection (at the injection site/sepsis)
  • Neurological disorders or cognitive impairment affecting pain perception
  • Pregnancy, breastfeeding
  • Patients under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophendexketoprofen trometamolFentanyl

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Omer Kayar, Medicinae Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiology and Reanimation Doctor

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start (Estimated)

June 2, 2026

Primary Completion (Estimated)

June 2, 2027

Study Completion (Estimated)

July 2, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations