BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty
Recruiting now · Not applicable
Conditions studied: Knee Arthroplasty, Total
In brief
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.
Key facts
- Study ID
- NCT06746168
- Run by
- Jessa Hospital
- People needed
- 210
- Starts
- 2025-01-09
- Expected to finish
- 2027-11-30
- Last updated by the study team
- 2025-02-20
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ASA I-III
- BMI 17-35 kg/m2
- Patient is able to give informed consent
- Patient is scheduled for TKA
You may not qualify if…
- 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
Where it is running
- Jessa Hospital — Hasselt, Limburg, Belgium (enrolling)
Full record on ClinicalTrials.gov
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