Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of periarticular injection with 0.25% bupivacaine for controlling pain after total knee replacement to improve the quality of post-operative care.

Detailed Description
-----------------
Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.

Official Title
-----------------
Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

Conditions
-----------------
Pain, Postoperative, Arthropathy of Knee Joint

Intervention / Treatment
-----------------
* Drug: 0.25% Bupivacaine
* Drug: 0.9% normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital BMI between 20-35 having a full understanding of the question in this trial Exclusion Criteria: allergy to NSAIDs, Acetaminophen, Bupivacaine blood creatinine more than 1.5 mg/dl or creatinine clearance less than 60 mL/min abnormal liver function previous surgery on the knee undergoing total knee replacement patient could not receive spinal anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.25% Bupivacaine<br>Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure. | Drug: 0.25% Bupivacaine<br>* Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.<br>* Other names: Marcaine;|
| Placebo Comparator: 0.9% normal saline<br>Periarticular injection with 20 ml of 0.9% normal saline before wound closure. | Drug: 0.9% normal saline<br>* Periarticular injection with 20 ml of 0.9% normal saline before wound closure.<br>* Other names: Isotonic saline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Measure by Visual analog scale scores and morphine consumption | 96 hour post operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication of Morphine consumption | nausea, pruritis, urinary retention and constipation | 96 hour post operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post operative pain, Total knee replacement, Total knee arthroplasty, Bupivacaine, Periarticular injection, Placebo, Morphine consumption