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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iPACK with Femoral Triangle Block (FTB) | Active Comparator | Patients undergoing an unillateral total kneearthroplasty will receive the anesthetic combination iPACK with FTB. |
|
| Surgical Local Infiltration Analgesia (LIA) | Active Comparator | Patients undergoing an unillateral total kneearthroplasty will receive the surgical LIA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bjorn Stessel, MD, PhD | Contact | 003211222107 | bjorn.stessel@jessazh.be | |
| Ina Callebaut, PhD | Contact | 003211339848 | ina.callebaut@jessazh.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Recruiting | Hasselt | Limburg | 3500 | Belgium |
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| Local Anesthetic Ropivacaine | Procedure | The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement. |
|
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:
| during hospital stay, an average of 3 days |