Actively Recruiting
Infiltration of Local Anesthetics Between the Popliteal Artery and Capsule of the Knee (iPACK) With Femoral Triangle Block Versus Surgical Local Infiltration Analgesia in Unilateral Total Knee Arthroplasty: A Multicenter Double-blind, Prospective Randomized Controlled Study
Led by Jessa Hospital · Updated on 2025-02-20
210
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of anesthetic techniques for patients undergoing unilateral total knee arthroplasty (TKA). The study evaluates whether the combination of an iPACK block with a femoral triangle block is as effective as the surgical local infiltration analgesia (LIA) for pain control after knee replacement surgery. The goal is also to see if the iPACK technique reduces risks like accidental nerve damage or local anesthetic toxicity compared to the traditional LIA method. Participants will be randomly assigned to one of two groups: one group receives the iPACK block with femoral triangle block using ropivacaine under ultrasound guidance after spinal anesthesia, and the other group receives surgical LIA with ropivacaine. The iPACK group gets 12 ml of 0.5% ropivacaine for the femoral triangle block and 20 ml of 0.5% ropivacaine for the iPACK block, while the LIA group receives 120 ml of 0.25% ropivacaine for surgical infiltration. During the study, pain will be measured using the Numerical Rating Scale (NRS) at 8 hours and throughout the first 24 hours after surgery. Functional recovery tests and quality of life questionnaires will be done at baseline and follow-ups up to 6 months. Researchers will also monitor the need for rescue pain relief, rate of popliteal block, and time to discharge. The study includes double-blind monitoring and randomization, with participation lasting through hospital stay and follow-up visits.
CONDITIONS
Brief Title
BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA physical status I to III
- Body mass index (BMI) between 17 and 35 kg/m2
- Able to give informed consent
- Scheduled for unilateral total knee arthroplasty (TKA)
You will not qualify if you...
- Patient refusal
- Inability to communicate due to language or neurological barriers
- Bilateral TKA or unilateral knee arthroplasty
- Chronic opioid use or chronic pain conditions
- Use of atypical analgesics such as gabapentin or pregabalin
- History of Sudeck atrophy or more than 3 chronic pain consultations
- Contraindications for spinal anesthesia
- Local infection
- Abnormal coagulation per ESRA guidelines
- Severe spinal canal stenosis
- Intracranial hypertension
- History of neurological injury in the affected limb
- Contraindications or allergy to local anesthetics
- Absolute contraindications or allergy to NSAIDs or paracetamol
- Severe renal impairment (eGFR less than 30 ml/min/1.73 m2)
- Active or recent history (within 6 months) of gastric ulcers, perforations, or bleeding
- Crohn disease or ulcerative colitis
- Liver function impairment
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During hospital stay, an average of 3 days
Participants receive unilateral total knee arthroplasty with either the iPACK with Femoral Triangle Block (FTB) locoregional anesthesia or surgical local infiltration analgesia (LIA) for pain control.
1 surgical visit and daily hospital visits for up to 3 days
Duration - Up to 6 months
Participants are monitored for pain scores, functional recovery, and quality of life after surgery.
Visits at baseline, 24 hours, 48 hours, 3 months, and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
Jessa Hospital
Hasselt, Limburg, Belgium, 3500
Actively Recruiting
Research Team
B
Bjorn Stessel, MD, PhD
I
Ina Callebaut, PhD
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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