Clinical trial NCT06746168: BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty
Official title: Infiltration of Local Anesthetics Between the Popliteal Artery and Capsule of the Knee (iPACK) With Femoral Triangle Block (TFB) Versus Surgical Local Infiltration Analgesia (LIA) in Unilateral Total Knee Arthroplasty (TKA): A Multicenter Double-blind, Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthroplasty, Total
Keywords: iPACK
Femoral Triangle Block
Local infiltration analgesia
knee arthoplasty
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively
timeFrame: 8 hours postoperatively
Secondary outcomes:
measure: NRS pain at movement for the first 24 hours
timeFrame: 24 hours postoperatively
measure: NRS pain at rest for the first 24 hours
timeFrame: 24 hours postoperatively
measure: Rate of popliteal block 8 hours after surgery
timeFrame: 8 hours postoperatively
measure: Functional recovery: timed up and go test
timeFrame: Baseline, 24 hours and 48 hours after surgery
measure: Functional recovery: 30-second sit-to-stand-chair test
timeFrame: Baseline, 24 hours and 48 hours after surgery
measure: Quality of Life: Short-form 36 (SF-36) questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Quality of Life: WOMAC questionnaire
timeFrame: Baseline, 3 months, 6 months
measure: Incidence of rescue blocks
timeFrame: 8 to 12 hours after the spinal anesthesia
measure: Need for rescue analgesia
timeFrame: during hospital stay, an average of 3 days
measure: Time to be fit for discharge
timeFrame: during hospital stay, an average of 3 days
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References: