LIA vs. LIA + ACB-iPACK Block for Total Knee Arthroplasty

Study Overview
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Brief Summary
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LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. The combination of ACB-iPACK blocks has also been proposed as an effective analgesic modality for total knee arthroplasty. However, whether combining these two modalities yields any important incremental analgesic benefit remains unclear. The investigators hypothesized that the addition of ACB and iPACK blocks to LIA will yield clinically important analgesic benefits compared to LIA alone in patients having total knee arthroplasty.

Detailed Description
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LIA is the mainstay of postoperative analgesia in patients having knee arthroplasty. Performed by surgeons, LIA provides effective postoperative pain relief and reduces opioid requirements. Similar analgesic benefits have also been attributed to adductor canal and iPACK blocks, which partially block sensory innervation to the knee and its posterior capsule. Performed by anesthesiologist preoperatively, these blocks have also been incorporated into the care standard in numerous centers. However, it is not clear whether adding the adductor canal and iPACK blocks yields any incremental analgesic benefits. The investigators aimed to evaluate the benefits of adding adductor canal and iPACK blocks to LIA in patients having total knee arthroplasty.

Official Title
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The Ideal Analgesic Technique for Total Knee Arthroplasty: A Randomized Comparison Between Local Infiltration Analgesia Alone or Combined With Adductor Canal and iPACK Blocks

Conditions
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Nerve Block, Neuromuscular Blockade

Intervention / Treatment
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* Procedure: Local infiltration analgesia
* Procedure: Ultrasound-guided adductor canal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA classification I-III BMI < 35 kg/m2 Having elective unilateral total knee arthroplasty Exclusion Criteria: Bilateral knee surgery. Pre-existing neurological deficit or peripheral neuropathy in the lower the lower limbs Severe, poorly controlled cardiac conditions, significant arrhythmias, severe valvular heart diseases Severe, poorly controlled respiratory conditions (severe COPD, severe interstitial lung disease, severe / poorly controlled asthma) Contraindication to regional anesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture on the posterior chest) Patient refusal Chronic pain disorder Chronic opioid use (≥30 mg oxycodone / day) Contraindication (or allergy) to a component of multi-modal analgesia protocol Allergy to amide local anesthetics used in nerve blocks Contraindications to spinal anesthesia Significant psychiatric disorder that would preclude objective study assessment Pregnancy Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, parallel group, triple blind (patient, assessor, anesthesiologist in the operating room)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local infiltration analgesia<br>Patients in this group will receive LIA intraoperatively, as per institutional standard. The injected solution will be comprised of 100cc Ropiv 2%, + Ketorolac 30 mg + Epinephrine 25 ug. | Procedure: Local infiltration analgesia<br>* Procedure: Local infiltration analgesia performed by surgeons.<br>|
| Active Comparator: Local infiltration analgesia + ACB-iPACK block<br>Patients in this group will receive LIA intraoperatively, as per institutional standard. The injected solution will be comprised of 100cc Ropiv 2%, + Ketorolac 30 mg + Epinephrine 25 ug. Patients in this group will also receive preoperative nerve blocks under ultrasound guidance. These will include: Adductor canal block with 0.5% Ropivacaine w/epi 20 mL iPack block with 0.25% Ropivacaine w/epi 10 mL | Procedure: Local infiltration analgesia<br>* Procedure: Local infiltration analgesia performed by surgeons.<br>Procedure: Ultrasound-guided adductor canal block<br>* Procedure: Ultrasound-guided adductor canal and iPACK blocks performed by anesthesiologists preoperatively.<br>* Other names: iPACK block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain at rest | Area under the curve | over the first 24 hours | 
| Quality of recovery (QoR-15) | Quality of Recovery (QR15) scores at 24 hours will be the second primary outcome. QR15 is a measurement of quality of recovery after surgery and anesthesia that has been psychometrically tested and validated. Reporting of outcome measures on a scale of 0 to 10 (0=None of the time and 10=All of the time). There are a total of 40 items/questions. | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean opioid analgesic consumption | Postoperative cumulative oral morphine equivalent consumption during the first 24 hours | 24 hours postoperatively | 
| Time to first analgesic request |  | Up to 48 hours following surgery | 
| Pain Assessment (VAS) | Visual Analogue Scale(VAS) - Pain:Overall pain assessed at rest and on movement A continuous scale comprised of a 100mm (10cm) horizontal line, anchored by 2 verbal descriptions No Pain to Worst Pain | at 0, 6, 12, 18 and 24 hours | 
| Risk of opioid-related side effects | nausea, vomiting, pruritus, sedation | Up until one month following nerve block | 
| Block-related complications | vascular puncture, hematoma formation, intravascular injection, epidural anesthesia-bilateral sensory block | Up until one month following nerve block | 
| Satisfaction with pain management | A Patient Diary will be completed to assess overall satisfaction with analgesic technique 10 cm scale with not satisfied at all and very satisfied at either end | at 24 hours |