- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07577869
Biceps Femoris Short Head (BiFeS) Block and Adductor Canal Block for Postoperative Analgesia Following Total Knee Arthroplasty (BiFeS Adductor)
A Comparison of the Effects of Biceps Femoris Short Head Block and Adductor Canal Block in Total Knee Arthroplasty on Postoperative Analgesia Using Multimodal Analgesia Methods
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Total knee arthroplasty is associated with significant postoperative pain and high opioid consumption. Peripheral nerve blocks are increasingly used as part of multimodal analgesia strategies to reduce opioid requirements and improve postoperative recovery.
This prospective, randomized, single-center clinical study will be conducted at Kayseri City Hospital Department of Anesthesiology and Reanimation. Sixty adult patients undergoing elective unilateral total knee arthroplasty under spinal anesthesia will be enrolled after written informed consent.
Participants will be randomized into two groups using the closed envelope method.
Intervention Group (n=30):
Patients will receive spinal anesthesia with 3.5-4 mL 0.5% hyperbaric bupivacaine. Before surgical incision, ultrasound-guided BiFeS block will be performed using 25 mL of 0.25% bupivacaine, followed by ultrasound-guided adductor canal block using 15 mL of 0.25% bupivacaine.
Control Group (n=30):
Patients will receive spinal anesthesia only without peripheral nerve block.
All patients will receive standard multimodal analgesia including intravenous paracetamol 1 g every 8 hours and intravenous dexketoprofen 50 mg every 12 hours. Postoperative analgesia will be provided using morphine PCA prepared as 1 mg/mL concentration with 15-minute lockout interval and maximum 4 boluses per hour.
Rescue analgesia will be administered as intravenous fentanyl 25 mcg in patients with NRS score ≥4 despite PCA use.
Primary outcome measure is total morphine consumption during the first 24 postoperative hours.
Secondary outcome measures include Numeric Rating Scale pain scores at postoperative 1, 6, 12, and 24 hours, time to first analgesic requirement, time to first active foot movement, rescue analgesic requirement, and postoperative Quality of Recovery-15 scores.
The study hypothesis is that combined BiFeS and adductor canal block will reduce postoperative opioid consumption and improve recovery quality compared with standard multimodal analgesia alone.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Omer Kayar, Medicinae Doctor
- Numero di telefono: +90 531 578 90 37
- Email: dr.omer.kayar@hotmail.com
Luoghi di studio
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Kocasinan
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Kayseri, Kocasinan, Turchia (Türkiye), 38080
- Kayseri City Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients aged 18 and older
- ASA I-III
- Patients scheduled for elective unilateral knee replacement
- Eligibility for and consent to spinal anesthesia
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Block Group
Patients receive spinal anesthesia followed by ultrasound-guided BiFeS block and adductor canal block before surgery, plus standard multimodal analgesia and morphine PCA.
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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.
Altri nomi:
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Comparatore attivo: Multimodal Analgesia Group
Patients receive spinal anesthesia only, followed by standard multimodal analgesia and morphine PCA.
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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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total Morphine Consumption in 24 Hours
Lasso di tempo: Within the first 24 hours after surgery
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Total cumulative morphine consumption measured from patient-controlled analgesia device during the first 24 postoperative hours.
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Within the first 24 hours after surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Numeric Rating Scale (NRS) Pain Scores
Lasso di tempo: Postoperative 1, 6, 12, and 24 hours
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Pain intensity measured using NRS at rest (0-10 scale).
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Postoperative 1, 6, 12, and 24 hours
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Time to First Analgesic Requirement
Lasso di tempo: 24 hours
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Time from end of surgery to first patient-reported pain requiring analgesic medication.
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24 hours
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Time to First Foot Movement
Lasso di tempo: 24 hours
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Time from completion of surgery to first active foot movement.
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24 hours
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QoR-15 Score
Lasso di tempo: 24 hours postoperatively
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Postoperative quality of recovery will be assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15), which evaluates patient well-being, physical comfort, emotional state, psychological support, and pain.
Total scores range from 0 to 150, with higher scores indicating better postoperative recovery.
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24 hours postoperatively
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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Complicanze postoperatorie
- Processi patologici
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Dolore, Postoperatorio
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Anilides
- Amides
- Composti di anilina
- Ammine
- Acetanilides
- Piperidine
- Acetaminofene
- Fentanil
- dexketoprofen trometamol
Altri numeri di identificazione dello studio
- KSH-ANES-2026/77
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