- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Omer Kayar, Medicinae Doctor
- Phone Number: +90 531 578 90 37
- Email: dr.omer.kayar@hotmail.com
Study Locations
-
-
Kocasinan
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Kayseri, Kocasinan, Turkey (Türkiye), 38080
- Kayseri City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
|
|
Active Comparator: Multimodal Analgesia Group
Patients receive spinal anesthesia only, followed by standard multimodal analgesia and morphine PCA.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Morphine Consumption in 24 Hours
Time Frame: Within the first 24 hours after surgery
|
Total cumulative morphine consumption measured from patient-controlled analgesia device during the first 24 postoperative hours.
|
Within the first 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale (NRS) Pain Scores
Time Frame: Postoperative 1, 6, 12, and 24 hours
|
Pain intensity measured using NRS at rest (0-10 scale).
|
Postoperative 1, 6, 12, and 24 hours
|
|
Time to First Analgesic Requirement
Time Frame: 24 hours
|
Time from end of surgery to first patient-reported pain requiring analgesic medication.
|
24 hours
|
|
Time to First Foot Movement
Time Frame: 24 hours
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Time from completion of surgery to first active foot movement.
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24 hours
|
|
QoR-15 Score
Time Frame: 24 hours postoperatively
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Anilides
- Amides
- Aniline Compounds
- Amines
- Acetanilides
- Piperidines
- Acetaminophen
- Fentanyl
- dexketoprofen trometamol
Other Study ID Numbers
- KSH-ANES-2026/77
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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