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

Jessa Hospital

Status: Enrolling

Conditions: Knee Arthroplasty, Total

Treatments: Procedure: Locoregional anesthesia; Procedure: Local Anesthetic Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06746168

2024/178

Details and patient eligibility

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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210 participants in 2 patient groups

iPACK with Femoral Triangle Block (FTB)

Active Comparator group

Description:

Patients undergoing an unillateral total kneearthroplasty will receive the anesthetic combination iPACK with FTB.

Treatment:

Procedure: Locoregional anesthesia

Surgical Local Infiltration Analgesia (LIA)

Active Comparator group

Description:

Patients undergoing an unillateral total kneearthroplasty will receive the surgical LIA.

Treatment:

Procedure: Local Anesthetic Ropivacaine