Improving pain control after knee surgery
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.
This study is testing a new way to manage pain after knee surgery to see if it works better and is safer than the usual method for patients having total knee replacements.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Jessa Hospital Academic / other |
| Locations | 1 site (Hasselt, Limburg) |
| Trial ID | NCT06746168 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of an iPACK block combined with a femoral triangle block against traditional surgical local infiltration analgesia (LIA) for patients undergoing unilateral total knee arthroplasty (TKA). The hypothesis is that the iPACK approach is at least as effective as the standard LIA while potentially reducing risks associated with nerve damage and other complications. The study will involve administering locoregional anesthesia using ropivacaine to assess pain management outcomes post-surgery.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for unilateral total knee arthroplasty with an ASA classification of I-III and a BMI between 17-35 kg/m2.
Not a fit: Patients with chronic pain issues, bilateral knee surgeries, or contraindications to local anesthetics will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better pain management and recovery experiences for patients undergoing knee arthroplasty.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving pain management techniques in orthopedic surgeries.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hasselt, Limburg
- Jessa Hospital — Hasselt, Limburg, Belgium (Recruiting)
Study contacts
- Study coordinator: Bjorn Stessel, MD, PhD
- Email: bjorn.stessel@jessazh.be
- Phone: 003211222107
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.