The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).

Official Title
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The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty

Conditions
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Knee Arthroplasty, Total

Intervention / Treatment
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* Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for total knee arthroplasty American Society Anesthesiologists (ASA) physical status I- III. Mentally competent and able to give consent for enrollment in the study. Exclusion Criteria: Patient refusal, allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3). Revision surgery will be excluded. Impaired kidney functions patient with coagulopathy will be also excluded. Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery. BMI of 45 or more

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACB + iPACK<br>Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). | Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)<br>* nerve block for posterior knee pain after a TKA.<br>* Other names: iPACK;|
| No Intervention: ACB w/o iPACK<br>Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients presenting with pain in the back of the knee 6 hours after surgery | Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator | Six hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score measurement reported by patients | Average of pain scores over the first 24 hours following the regional anesthetic based on numeric rating scale ( NRS). The scale is from 0 - 10, where 0 is no pain and 10 is the worst pain possible. | 24 hours after surgery | 
| Quality of recovery (QoR) score | Score of QoR-15 survey to determine recovery status. the questionnaire is a 15 item questionnaire and each question has a score possible from 0-10. It has two parts.Part 1 includes questions from 1-10. the scale on this question ranges from 0=none of the time ( poor) to 10=all the time ( excellent). the second part include questions from 11-15 where the scale goes from 10 to 0, where 10=none of the time ( excellent) and 0=all the time (poor). the total score is obtained by adding the scores of all the 15 questions | one week, measurements are obtained at 24 hours, 48 hours, and one week |