Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT06746168
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06746168
Study Brief:
Protocol Section:
NCT06746168