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NCT Number: NCT06746168

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

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.

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Key information

Conditions

Knee Arthroplasty, Total

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location status: Recruiting

Location contact

Bjorn Stessel, MD, PhD

CONTACT

[email protected]

Bjorn Stessel, MD, PhD

SUB_INVESTIGATOR

Ina Callebaut, PhD

CONTACT

[email protected]

+33211339848

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Locoregional anesthesia

Procedure

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

Local Anesthetic Ropivacaine

Procedure

The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.

Primary outcomes

  1. Numerical Rating Scale (NRS) pain score at mobilization at 8 hour postoperatively

    Time frame: 8 hours postoperatively

    The NRS pain score will be determined immediately after mobilizing patients from the bed to their seat at 8 hour postoperatively

Secondary outcomes

  1. NRS pain at movement for the first 24 hours

    Time frame: 24 hours postoperatively

    The Area Under the Curve for the NRS pain scores at movement will be evaluated at 4h-6h-8h-12h-24h after the surgery

  2. NRS pain at rest for the first 24 hours

    Time frame: 24 hours postoperatively

    The Area Under the Curve for the NRS pain scores at rest will be evaluated at 4h-6h-8h-12h-24h after the surgery

  3. Rate of popliteal block 8 hours after surgery

    Time frame: 8 hours postoperatively

    the incidence of a popliteal block will be assessed 8 hours after surgery

  4. Functional recovery: timed up and go test

    Time frame: Baseline, 24 hours and 48 hours after surgery

    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.

  5. Functional recovery: 30-second sit-to-stand-chair test

    Time frame: Baseline, 24 hours and 48 hours after surgery

    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.

  6. Quality of Life: Short-form 36 (SF-36) questionnaire

    Time frame: Baseline, 3 months, 6 months

    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.

  7. Quality of Life: WOMAC questionnaire

    Time frame: Baseline, 3 months, 6 months

    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.

  8. Incidence of rescue blocks

    Time frame: 8 to 12 hours after the spinal anesthesia

    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.

  9. Need for rescue analgesia

    Time frame: during hospital stay, an average of 3 days

    The need and dose for rescue analgesia (oral morphine equivalents) will be calculated

  10. Time to be fit for discharge

    Time frame: during hospital stay, an average of 3 days

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bjorn Stessel, MD, PhD

CONTACT

[email protected]

003211222107

Ina Callebaut, PhD

CONTACT

[email protected]

003211339848

Sponsors and collaborators

Lead sponsor

Jessa Hospital

Other

Registry information

Official study 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.

Acronym: BLOCK

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Dec 24, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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