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

Jessa Hospital210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

210

Conditions

Knee Arthroplasty, Total

Interventions

Locoregional anesthesiaPROCEDURE

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 RopivacainePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Jessa Hospital

Hasselt, Limburg, Belgium

RECRUITING

Outcomes

Primary Outcomes

Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively

The NRS pain score will be determined immediately after mobilizing patients from the bed to their seat at 8 hour postoperatively

Time frame: 8 hours postoperatively

Secondary Outcomes

NRS pain at movement for the first 24 hours

The Area Under the Curve for the NRS pain scores at movement will be evaluated at 4h-6h-8h-12h-24h after the surgery

Time frame: 24 hours postoperatively

NRS pain at rest for the first 24 hours

The Area Under the Curve for the NRS pain scores at rest will be evaluated at 4h-6h-8h-12h-24h after the surgery

Time frame: 24 hours postoperatively

Rate of popliteal block 8 hours after surgery

the incidence of a popliteal block will be assessed 8 hours after surgery

Time frame: 8 hours postoperatively

Functional recovery: timed up and go test

Patients have to sit in a standard sitting chair, stand up from the chair, walk 3 meters, get back to the chair and sit down. A cut-off of 13.5 seconds or longer indicates higher risk of falls, normal values depend on age.

Time frame: Baseline, 24 hours and 48 hours after surgery

Functional recovery: 30-second sit-to-stand-chair test

In the 30 seconds sit-to-stand chair test, patients must try to stand up and sit down again from a chair as much as possible in the 30 seconds time interval. Arms need to be crossed and may not be used to stand up. Normal values vary according to age.

Time frame: Baseline, 24 hours and 48 hours after surgery

Central Contacts

Bjorn Stessel, MD, PhD

CONTACT

003211222107 bjorn.stessel@jessazh.be

Ina Callebaut, PhD

CONTACT

003211339848 ina.callebaut@jessazh.be

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.