Efficacy of Peripheral Nerve Blocks in Total Knee Arthroplasty
NCT ID: NCT07040709
Last Updated: 2025-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
86 participants
INTERVENTIONAL
2025-06-08
2026-06-01
Brief Summary
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Detailed Description
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Patients will be randomly assigned into two groups using a computer-generated randomization: the adductor canal block group (Group A) and the suprainguinal fascia iliaca plane block group (Group S). Postoperative monitoring in the recovery unit will include non-invasive measurements of ECG, blood pressure, heart rate, and SpO2.
According to their assigned group, patients will receive either ultrasound-guided suprainguinal fascia iliaca plane block or adductor canal block for postoperative analgesia control. Patients will be observed in the recovery room for an adequate period, after which a patient-controlled analgesia (PCA) pump will be routinely applied in our clinic. The PCA will be infused with an opioid-containing solution at an appropriate dose, and detailed patient information will be provided. Instead of continuous infusion, the device will deliver bolus doses intermittently when the patient's numeric rating scale (NRS) score reaches 4 or higher. If the patient's pain score remains 4 or above despite analgesic administration, routine intramuscular dicloron as rescue analgesia will be administered in our clinic. Patients will be periodically visited in bed, and data will be recorded regarding pain scores, motor strength of the operated limb, opioid consumption, use of rescue analgesia, and any complications. Follow-up assessments will be performed by a single experienced Anesthesiology and Reanimation specialist.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group A
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an adductor canal block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
Opioid Analgesic (tramadol hydrochloride)
For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher.
Prophylactic analgesia (intravenous paracetamol)
All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief).
Rescue analgesia (intramuscular diclofenac sodium)
If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered.
Group S
A patient who underwent total knee arthroplasty under spinal anesthesia will receive an suprainguinal fascia iliac plane block, which is routinely performed with ultrasound guidance at our clinic for postoperative pain management. Postoperative patients will be visited at the 1st, 3rd, 6th, 9th, 12th, 15th, 18th, 21st, and 24th hours to assess pain, nausea, vomiting, itching, motor strength of the operated leg, and total opioid consumption.
Opioid Analgesic (tramadol hydrochloride)
For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher.
Prophylactic analgesia (intravenous paracetamol)
All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief).
Rescue analgesia (intramuscular diclofenac sodium)
If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered.
Interventions
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Opioid Analgesic (tramadol hydrochloride)
For postoperative pain management, a patient-controlled analgesia (PCA) pump will be routinely applied to the patient in our clinic. An infusion of an opioid (tramadol hydrochloride) at an appropriate dose will be administered via intravenous route through the pump, and the patient will be provided with detailed information about its use. Instead of continuous infusion, the device will deliver intermittent bolus doses when the patient's numeric rating scale (NRS) score is 4 or higher.
Prophylactic analgesia (intravenous paracetamol)
All patients will receive routine prophylactic analgesia with 1 gram of intravenous paracetamol every 6 hours (which may be skipped if the patient's pain score is 2 or below and they do not request pain relief).
Rescue analgesia (intramuscular diclofenac sodium)
If the pain persists despite the administered analgesics and the patient's pain score remains 4 or above, rescue analgesia with intramuscular diclofenac sodium, which is routinely used in our clinic, will be administered.
Eligibility Criteria
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Inclusion Criteria
* Patients classified as ASA I, II, or III based on physical status
* Patients scheduled for total knee arthroplasty under spinal anesthesia
Exclusion Criteria
* Patients with a history of allergy to opioids or local anesthetics.
* Patients with psychiatric disorders that may impair cooperation.
* Patients with bleeding disorders or those using anticoagulant therapy.
* Patients unwilling to participate voluntarily in the study.
18 Years
75 Years
ALL
No
Sponsors
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Tokat Gaziosmanpasa University
OTHER
Responsible Party
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Ali Genc
Assistant professor
Locations
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Tokat Gaziosmanpasa University
Tokat Province, ABD Veya Kanada'daysanız Lütfen Seçin..., Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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24-AKD-143
Identifier Type: -
Identifier Source: org_study_id
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