Kayseri City Hospital
Kayseri, Kocasinan, 38080, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07577869
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Kayseri, Kocasinan, 38080, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Procedure: Adductor Canal Block, Drug: Morphine PCA, Drug: Paracetamol, Drug: Dexketoprofen, Drug: Fentanyl
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: Drug: Morphine PCA, Drug: Paracetamol, Drug: Dexketoprofen, Drug:Fentanyl
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.
Time frame: Postoperative 1, 6, 12, and 24 hours
Pain intensity measured using NRS at rest (0-10 scale).
Time frame: 24 hours
Time from end of surgery to first patient-reported pain requiring analgesic medication.
Time frame: 24 hours
Time from completion of surgery to first active foot movement.
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.
Contact information is provided by the study sponsor or research team.
Ömer Kayar
Other Gov
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
Acronym: BiFeS Adductor
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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