Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.

Detailed Description
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There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).

Official Title
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Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Device: Ipack
* Drug: Bupivacaine
* Procedure: Peri Articular Infiltration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA (American Society of Anesthesiology) class I-IV age 18-75. Exclusion Criteria: ASA class V morbid obesity patient refusal patients with chronic pain or on pain medication allergy to LA patients receiving any additional regional techniques coagulopathy patients receiving systemic anticoagulation local infection and procedures anticipated to last more than 5 hours.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ipack group<br>20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well. | Device: Ipack<br>* IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.<br>Drug: Bupivacaine<br>* 20 cc of bupivacaine(o.25%) injection<br>Procedure: Peri Articular Infiltration<br>* Adductor Canal Catheter and Peri Articular Infiltration<br>* Other names: PAI;|
| Active Comparator: Pai (peri articular) group<br>Patients will receive adductor canal catheter and peri articular infiltration. | Procedure: Peri Articular Infiltration<br>* Adductor Canal Catheter and Peri Articular Infiltration<br>* Other names: PAI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotic Consumption | Narcotic consumption in the first 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score (VAS) for Pain | Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain. | at 6, 12, 18, and 24 hours post procedure | 
| Time to First Dose of Narcotic Administration |  | up to 24 hours | 
| PACU Length of Stay | Post-Anesthesia Care Unit (PACU) length of stay (LOS) | average 24 hours | 
| Number of Participants With Pain by Location | Location of knee pain as anterior/posterior, medial/lateral | 24 hours | 
| Ambulation Distance | Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT | Post-op Day 1 | 
| Bartels Index | Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence. | Post-op Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total knee arthroplasty, Peri articular infiltration, Pack block, Adductor canal catheter