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Clinical Trials in Belgium / NCT06746168
Recruiting Not applicable

BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty

NCT06746168 · tracked via the Priya Life Science Belgium tracker
Sponsor
Jessa Hospital
Phase
Not applicable
Started
2025-01-09
Last updated
2025-02-20

Condition(s) studied

Knee Arthroplasty, Total

Investigational drug(s) / intervention(s)

Locoregional anesthesiaLocal Anesthetic Ropivacaine

Locoregional anesthesia: The FTB + iPACK group will receive 12 ml 0,5% ropivacaine for the FTB and 20 ml of ropivacaine 0.5% for the iPACK block under US guidance after spinal anesthesia

Local Anesthetic Ropivacaine: The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

Study summary

The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * ASA I-III * BMI 17-35 kg/m2 * Patient is able to give informed consent * Patient is scheduled for TKA Exclusion Criteria: * Refusal of patient * Inability to communicate due to language or neurologic barriers * Bilateral TKA or unilateral knee arthroplasty * Chronic opioid use (including partial opioid agonists) + chronic pain patients: * Use of atypical analgesics (gabapentin, pregabalin, …) * History of Sudeck atrophy * History of \>3 chronic pain consultations * Contraindications for spinal anesthesia * Patient refusal * Local infection * Aberrant coagulation (according to the latest ESRA guidelines) * Severe spinal canal stenosis * Intracranial hypertension * History of neurological injury in the affected limb * Contraindications for local anesthetics * Allergy for local anesthetics * Absolute contraindications for NSAIDs or paracetamol * Proven allergy for NSAID's (including ASA syndrome) or paracetamol * Severe renal function impairment (eGFR \<30 ml/min/1.73 m2) * Active or recent (\<6 months) history of gastric ulcera/perforations/bleeding * Crohn disease or colitis ulcerosa * Liver function impairment or severe renal function impairment (eGFR \<30 ml/min/1.73 m2) * Pregnancy or breast-feeding

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Jessa Hospital Hasselt Limburg Recruiting

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Other trials for the same condition

LEGION Hinge Safety and Efficacy Study Active, not recruiting
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 NCT06746168 on ClinicalTrials.gov ↗ ← All trials in Belgium