Traditional vs Oral Fluid Management in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. This study will investigate the effects of two regimens of intraoperative fluid management (traditional vs. oral) with physiologic and patient function as primary outcome measures after surgery.

Detailed Description
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Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Typical intraoperative and post-operative fluid management has been arbitrary without evidence based guidelines established following total joint replacement. The investigators have observed many patients post-operatively with side effects such as fluid overload leading to medical complications requiring either prolonged hospitalization or readmission. Additionally, this overload may lead to wound healing complications secondary to fluid shifts which may be devastating in this patient population. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. Additionally, this increase fluid may be detrimental in patients with anastomosis leading to failure and/or complications in this patient population. The investigators have defined to specific groups of interest to study in this patient population with regards to fluid management. The first group is the traditional IV fluid group where the anesthesiologist gives an unspecific amount of fluid intraoperatively and post-operatively the patient gets a set amount of fluid based on protocol on the orthopaedic floor (i.e. 75 cc/hour until good oral intake). This is the protocol utilized by most orthopaedic practices throughout the United States. The second group is defined as patients who are given a specific protocol preoperatively to optimize hydration, followed by limited fluids intraoperatively based on physiologic parameters. This study will investigate the effects of two regimens of intraoperative fluid management (traditional vs. oral) with

Official Title
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Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Other: Pre Operative Oral Fluids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients between the ages of 18-75 years old undergoing a primary total knee arthroplasty for a diagnosis of degenerative osteoarthritis who do not meet the exclusion criteria listed below Exclusion Criteria: Volume-dependent cardiac conditions: Aortic stenosis Pulmonary valve stenosis Subaortic stenosis Severe Aortic Insufficiency Chronic systolic heart failure Eisenmeinger Syndrome Severe pulmonary HTN Chronic or paroxysmal dysrhythmias Pre-operative electrolyte abnormalities Abnormalities of the HPA (hypothalamic-pituitary axis) Stage 3 Chronic Kidney Disease (or worse) Patients taking angiotensin receptor blockers (ARB) Patients with uncontrolled diabetes mellitus (patient with A1C of 7+ or on insulin) Patients whose BMI is > 35 38 or < 19 Current use of long acting narcotic medication or 3 or more months of daily short acting narcotic medication Patients at risk for electrolyte abnormalities, dehydration or intra-operative hypotension. (patients taking angiotensin receptor blockers, ACE inhibitors (48 hours prior to surgery) and Diuretics) Patients with severe, untreated or uncontrolled GERD. Patients that cannot receive spinal anesthesia (e.g. patient with back fusions) Pre-Operative Anemia

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional Fluid<br>NPO Clears and Food after midnight. 2 Liters of lactated ringers administered by anesthesia intraoperatively. Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters). Normal diet postoperatively. | |
| Experimental: Oral Fluid<br>Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.) NPO Food/Milk: none beginning 8 hours prior to procedure time. Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.) Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total. PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days. | Other: Pre Operative Oral Fluids<br>* Patients will be self hydrating prior to their total knee replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight | Patient Weight will be monitored | Change is patients weight from baseline at pre op to two weeks post op. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Range of Motion | Measurements will be done with a standard goniometer (Measurements below are shown as the difference from their pre operative base line measurement to the time points below) | Post Op Day 1, 2 Weeks and 6 Weeks Post Op | 
| Leg Anthropometric (Girth) Measurements | measurements will be performed at 5 & 10 cm suprapatellar, midpatella, and 10 cm infrapatellar with the use of a standard tape measure. measurements below show the difference from their pre operative base line measurement to the timepoints below. | Post op Day 1, 2 weeks and 6 weeks Post Op | 
| Number of Participants With Requiring Transfusions | Post Operative/Intra Operative Transfusions | intra operative, Post Op Day #1 or #2 | 
| Number of Participants With Off Wound Complications Post Operative | incidence of wound infection and wound drainage will be assessed and recorded | Up to 6 weeks Post OP | 
| Number of Participants With Thromboembolic Disease | The incidence of thromboembolic events will be recorded. | Post Opeartive until the 6 week follow up appointment | 
| Quadriceps Strength Measure With a Handheld Dynamometer | The strength testing will be calculated using a handheld dynamometer | Post Op day 1, 2 Week and 6 Week Post OP | 
| Time up and GO | timed up and go (TUG) | preoperative appointment and once again at their 2 and 6 weeks postoperatively | 
| 30 Second STS Test | 30 second sit-to-stand tests | preoperative appointment and once again at their 2 and 6 weeks postoperatively | 
| Length of the Hospitalization | Length of time the patient is Hospitalized after their total knee replacement. | Daily up to 2 days while hospitalized | 
| Number of Patients Re-admitted Post TKA | Number of patients re-admitted post TKA | up to 6 weeks post op | 
| Postoperative Pain Assessment Using Visual Analog Scale | Pain will be assessed using a pain Visual Analog scale(VAS), the scale is from 1 to 10, the higher the score the worse the pain. | Every 4 hours, averaged daily, reported at Post op day 1 and 2 (while in the hospital), weeks 1, 2, 3, and 4 (3 times a day) | 
| PONV (Post-operative Nausea and Vomiting) | patients will be asked about Nausea: None, Mild, Moderate or Severe | Daily up to 2 days while hospitalized | 
| Veterans Rand -12 | Patient Reported Outcomes- Veterans Rand(VR-12), there is an algorithm to calculate this score, not a specific range. The higher the number the more positive the output. The score has two components a mental score (MCS) and Physical Score (PCS). Higher values represent a better outcome. MCS Scale 35.089613 to 46.341715 PCS Scale 14.957554 to 63.235672 | 2 week and 6 week follow up appointments | 
| Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee injury and Osteoarthritis Outcome Score (KOOS), the scale is 0 to 100, 100 being the best score possible. | pre-operatively as well as at their 2 week and 6 week follow up appointments | 
| Patient Reported Outcomes - Knee Society Score(KSS) | Knee Society Score(KSS), the total scores range from 0 - 200, 200 being the best. | pre-operatively as well as at their 2 week and 6 week follow up appointments | 
| Total IV Fluids Received | Total amount of IV fluids that the patients received while in the hospital | Duration of IV intervention, up to 2 days | 
| Bioimpedence | body composition before and after surgery to measure swelling. Lower numbers represent more swelling. | pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid Management