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

Official title

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.

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.

Interventions

• Procedure Locoregional anesthesia
  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
• Procedure Local Anesthetic Ropivacaine
  The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

Primary outcome measures

• Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively [Time frame: 8 hours postoperatively]

Secondary outcome measures (10)

• NRS pain at movement for the first 24 hours [Time frame: 24 hours postoperatively]
• NRS pain at rest for the first 24 hours [Time frame: 24 hours postoperatively]
• Rate of popliteal block 8 hours after surgery [Time frame: 8 hours postoperatively]
• Functional recovery: timed up and go test [Time frame: Baseline, 24 hours and 48 hours after surgery]
• Functional recovery: 30-second sit-to-stand-chair test [Time frame: Baseline, 24 hours and 48 hours after surgery]
• Quality of Life: Short-form 36 (SF-36) questionnaire [Time frame: Baseline, 3 months, 6 months]
• Quality of Life: WOMAC questionnaire [Time frame: Baseline, 3 months, 6 months]
• Incidence of rescue blocks [Time frame: 8 to 12 hours after the spinal anesthesia]
• Need for rescue analgesia [Time frame: during hospital stay, an average of 3 days]
• Time to be fit for discharge [Time frame: during hospital stay, an average of 3 days]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Double blind

Primary purpose

Treatment

Study locations

Belgium · 1 center

• Jessa Hospital — Hasselt

Identifiers

NCT: NCT06746168 · 2024/178

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗