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Starting soon Not applicable

GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty

NCT07901348 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-12-01
Last updated
2026-10-28

Condition(s) studied

Arthroplasty, Replacement, KneePain, PostoperativeOsteoarthritis, Knee

Investigational drug(s) / intervention(s)

GENIVS blockAdductor Canal Block (ACB) Only

GENIVS block: Ultrasound-guided single-injection periosteal plane block. A linear probe is placed transversely on the medial distal thigh at or just distal to the apex of the femoral triangle and rotated about 45 degrees. The needle is advanced in-plane from medial to lateral until it contacts the anteromedial femoral periosteum beneath the vastus medialis. After bone contact is confirmed and the needle-tip position is checked with 1-2 mL of 5% dextrose, 20 mL of 0.375% bupivacaine (75 mg) is injected in 5-mL aliquots with intermittent aspiration, aiming for distal and circumferential periosteal spread.

Adductor Canal Block (ACB) Only: Ultrasound-guided single-injection adductor canal block at mid-thigh (midpoint between the inguinal ligament and the superior border of the patella). The needle is advanced in-plane from lateral to medial beneath the sartorius muscle next to the femoral artery. After the needle-tip position is checked with 1-2 mL of 5% dextrose, 20 mL of 0.375% bupivacaine (75 mg) is injected in 5-mL aliquots with intermittent aspiration so that it spreads around the artery.

Study summary

The goal of this clinical trial is to learn whether the ultrasound-guided GENIVS block is not worse than (non-inferior to) the adductor canal block in reducing opioid use after total knee arthroplasty performed under spinal anesthesia. The main question it aims to answer is:

\- Is total opioid consumption (intravenous tramadol, mg) in the first 24 hours after surgery with the GENIVS block not clinically worse than with the adductor canal block?

Researchers will also compare pain scores, time to the first analgesic request, the need for rescue pain medication, mobilization (Timed Up and Go test and stair climbing), quality of recovery (QoR-15) and opioid-related side effects between the two groups.

Participants will:

* have elective, primary, one-sided knee replacement surgery under spinal anesthesia;
* be randomly assigned to receive either a GENIVS block or an adductor canal block, with the same local anesthetic dose, at the end of surgery;
* use an intravenous tramadol patient-controlled analgesia pump and receive standard pain treatment for 72 hours;
* rate their pain and complete mobility tests and questionnaires at scheduled times during the first 72 hours after surgery.

Eligibility

Sex
ALL
Min age
55 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Age 55 to 75 years * Scheduled for elective, primary, unilateral total knee arthroplasty * Surgery planned under spinal anesthesia * American Society of Anesthesiologists (ASA) physical status I, II or III * Able to walk without assistance or with a cane and to perform the Timed Up and Go test before surgery * Written informed consent Exclusion Criteria: * Revision or bilateral knee arthroplasty * Contraindication to spinal anesthesia or peripheral nerve block (bleeding disorder, anticoagulant therapy not discontinued according to guidelines, infection at the needle insertion site) * Known allergy to local anesthetics or to other study drugs * Body mass index above 40 kg/m² * Deformity, previous surgery or other pathology of the thigh that may hinder the block * Pre-existing neurological deficit or neuromuscular disease in the operative lower extremity * Regular opioid use for more than 3 months before surgery, or alcohol or substance dependence * Severe renal or hepatic failure * Dementia, psychiatric disease, cognitive impairment, or inability to understand pain scoring and the Timed Up and Go test despite preoperative instruction * Contraindication to tramadol, paracetamol or nonsteroidal anti-inflammatory drugs (e.g., uncontrolled epilepsy, use of monoamine oxidase inhibitors, active peptic ulcer or history of gastrointestinal bleeding, NSAID allergy) * Regular preoperative use of gabapentinoids (pregabalin or gabapentin)

Primary outcome measure(s)

  • Total opioid consumption in the first 24 hours — 0 to 24 hours after PCA connection
    Total opioid consumption, measured as the cumulative intravenous tramadol dose (mg) recorded by the patient-controlled analgesia device from PCA connection (hour 0) to 24 hours.

Trial sites (1)

FacilityCityRegionStatus
Bakirkoy Dr. Sadi Konuk Research and Training Hospital Istanbul Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07901348 on ClinicalTrials.gov ↗ ← All trials in Turkey