BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty (NCT06746168) | Clinical Trial Compass
RecruitingNot Applicable
BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty
Belgium210 participantsStarted 2025-01-09
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively