Knee Arthroplasty, TotalBLOCKNCT06746168
BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty
A study testing Locoregional anesthesia and Local Anesthetic Ropivacaine in people with Knee Arthroplasty, Total, run by Jessa Hospital at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Locoregional anesthesia and Local Anesthetic Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jan 2025to 30 Nov 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- BMI 17-35 kg/m2
- Patient is able to give informed consent
- Patient is scheduled for TKA
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Ina Callebaut, PhD, +33211339848, ina.callebaut@jessazh.be
Bjorn Stessel, MD, PhD, bjorn.stessel@jessazh.be
About this study
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.
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.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Locoregional anesthesia, Local Anesthetic Ropivacaine
- Keywords
- iPACK, Femoral Triangle Block, Local infiltration analgesia, knee arthoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locoregional anesthesiaProcedure or surgery
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 RopivacaineProcedure or surgery
The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.
| Study group | Role | What they receive |
|---|---|---|
| iPACK with Femoral Triangle Block (FTB) | Active comparator | Patients undergoing an unillateral total kneearthroplasty will receive the anesthetic combination iPACK with FTB. Receives: Procedure: Locoregional anesthesia |
| Surgical Local Infiltration Analgesia (LIA) | Active comparator | Patients undergoing an unillateral total kneearthroplasty will receive the surgical LIA. Receives: Procedure: Local Anesthetic Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 hours postoperatively
Secondary outcomes (10)
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
Measured: 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
Measured: 24 hours postoperatively
Rate of popliteal block 8 hours after surgery
the incidence of a popliteal block will be assessed 8 hours after surgery
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: during hospital stay, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start9 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746168
- Sponsor's protocol ID
- 2024/178
- Acronym
- BLOCK
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No