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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Procedure: Locoregional anesthesia; Procedure: Local Anesthetic Ropivacaine

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bjorn Stessel, MD, PhD; Phone Number: 003211222107; Email: bjorn.stessel@jessazh.be
• Study Contact Backup: Name: Ina Callebaut, PhD; Phone Number: 003211339848; Email: ina.callebaut@jessazh.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: Ina Callebaut, PhD; Phone Number: +33211339848; Email: ina.callebaut@jessazh.be
      • Contact: Bjorn Stessel, MD, PhD; Phone Number: bjorn.stessel@jessazh.be
      • Contact: Bjorn Stessel, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: iPACK with Femoral Triangle Block (FTB); Patients undergoing an unillateral total kneearthroplasty will receive the anesthetic combination iPACK with FTB.	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
Active Comparator: Surgical Local Infiltration Analgesia (LIA); Patients undergoing an unillateral total kneearthroplasty will receive the surgical LIA.	Procedure: Local Anesthetic Ropivacaine; The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively	The NRS pain score will be determined immediately after mobilizing patients from the bed to their seat at 8 hour postoperatively	8 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS pain at movement for the first 24 hours	The Area Under the Curve for the NRS pain scores at movement will be evaluated at 4h-6h-8h-12h-24h after the surgery	24 hours postoperatively
NRS pain at rest for the first 24 hours	The Area Under the Curve for the NRS pain scores at rest will be evaluated at 4h-6h-8h-12h-24h after the surgery	24 hours postoperatively
Rate of popliteal block 8 hours after surgery	the incidence of a popliteal block will be assessed 8 hours after surgery	8 hours postoperatively
Functional recovery: timed up and go test	Patients have to sit in a standard sitting chair, stand up from the chair, walk 3 meters, get back to the chair and sit down. A cut-off of 13.5 seconds or longer indicates higher risk of falls, normal values depend on age.	Baseline, 24 hours and 48 hours after surgery
Functional recovery: 30-second sit-to-stand-chair test	In the 30 seconds sit-to-stand chair test, patients must try to stand up and sit down again from a chair as much as possible in the 30 seconds time interval. Arms need to be crossed and may not be used to stand up. Normal values vary according to age.	Baseline, 24 hours and 48 hours after surgery
Quality of Life: Short-form 36 (SF-36) questionnaire	The SF-36 questionaire is the most widely used health-related quality of life score. They identified 8 health concepts to be scored in the SF-36: Physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal/emotional problems, general mental health, social functioning, energy/fatigue/vitality and general health perceptions.	Baseline, 3 months, 6 months
Quality of Life: WOMAC questionnaire	The WOMAC-index (Western Ontario and McMaster Universities Osteoartritis index) evaluates the broader functional impact of (initially) osteoarthritis but is now often used as quality of life indicator after total knee arthroplasty.	Baseline, 3 months, 6 months
Incidence of rescue blocks	In case of persistent pain (NRS > 6) despite the abovementioned regimen (cut-off: need for more than 20 opioid oral morphine milligrams equivalents over 12h), a rescue femoral triangle (10-15 ml ropivacaine 0.5%) and iPACK block (20 ml ropivacaine 0.5%) can be applied 8-12h after the initial locoregional procedure.	8 to 12 hours after the spinal anesthesia
Need for rescue analgesia	The need and dose for rescue analgesia (oral morphine equivalents) will be calculated	during hospital stay, an average of 3 days
Time to be fit for discharge	- Time to be fit for discharge as defined by: Oral pain medication only; Independent walking (with crutches); Full oral diet; Hemodynamically and respiratory (no need for oxygen) stable; No drains or urinary catheters This will be assess until day of discharge	during hospital stay, an average of 3 days

Collaborators and Investigators

• Sponsor: Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Local infiltration analgesia; iPACK; knee arthoplasty; Femoral Triangle Block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Ropivacaine; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 2024/178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No