Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06746168

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

Led by Jessa Hospital · Updated on 2025-02-20

210

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA physical status I to III
  • Body mass index between 17 and 35 kg/m2
  • Ability to give informed consent
  • Scheduled for unilateral total knee arthroplasty
Not Eligible

You will not qualify if you...

  • Patient refusal to participate
  • Inability to communicate due to language or neurological issues
  • Bilateral or non-unilateral knee arthroplasty
  • Chronic opioid use or chronic pain patients
  • Use of atypical analgesics like gabapentin or pregabalin
  • History of Sudeck atrophy
  • More than three chronic pain consultations
  • Contraindications for spinal anesthesia
  • Local infection
  • Abnormal blood clotting per ESRA guidelines
  • Severe spinal canal stenosis
  • Intracranial hypertension
  • Previous neurological injury in the affected limb
  • Contraindications or allergies to local anesthetics
  • Absolute contraindications or allergies to NSAIDs or paracetamol
  • Severe kidney impairment (eGFR less than 30 ml/min/1.73 m2)
  • Active or recent gastric ulcers, perforations, or bleeding within 6 months
  • Crohn's disease or ulcerative colitis
  • Liver function impairment
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Jessa Hospital

Hasselt, Limburg, Belgium, 3500

Actively Recruiting

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Research Team

B

Bjorn Stessel, MD, PhD

CONTACT

I

Ina Callebaut, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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