Traditional vs Oral Fluid Management in Total Knee Arthroplasty

Not Applicable

Completed

Conditions: Arthroplasty, Replacement, Knee

Interventions: Other: Pre Operative Oral Fluids

Registration Number: NCT03719378

Lead Sponsor: Colorado Joint Replacement

Brief Summary: 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: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 150

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Fluid	Pre Operative Oral Fluids	* 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.

Primary Outcome Measures

Name	Time	Method
Body Weight	Change is patients weight from baseline at pre op to two weeks post op.	Patient Weight will be monitored

Secondary Outcome Measures

Name	Time	Method
Knee Range of Motion	Post Op Day 1, 2 Weeks and 6 Weeks Post Op	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)
Number of Participants With Thromboembolic Disease	Post Opeartive until the 6 week follow up appointment	The incidence of thromboembolic events will be recorded.
Number of Patients Re-admitted Post TKA	up to 6 weeks post op	Number of patients re-admitted post TKA
Postoperative Pain Assessment Using Visual Analog Scale	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)	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.
Patient Reported Outcomes - Knee Society Score(KSS)	pre-operatively as well as at their 2 week and 6 week follow up appointments	Knee Society Score(KSS), the total scores range from 0 - 200, 200 being the best.
Leg Anthropometric (Girth) Measurements	Post op Day 1, 2 weeks and 6 weeks Post Op	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.
Quadriceps Strength Measure With a Handheld Dynamometer	Post Op day 1, 2 Week and 6 Week Post OP	The strength testing will be calculated using a handheld dynamometer
Veterans Rand -12	2 week and 6 week follow up appointments	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
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)	pre-operatively as well as at their 2 week and 6 week follow up appointments	Knee injury and Osteoarthritis Outcome Score (KOOS), the scale is 0 to 100, 100 being the best score possible.
Total IV Fluids Received	Duration of IV intervention, up to 2 days	Total amount of IV fluids that the patients received while in the hospital
Number of Participants With Requiring Transfusions	intra operative, Post Op Day #1 or #2	Post Operative/Intra Operative Transfusions
Number of Participants With Off Wound Complications Post Operative	Up to 6 weeks Post OP	incidence of wound infection and wound drainage will be assessed and recorded
Time up and GO	preoperative appointment and once again at their 2 and 6 weeks postoperatively	timed up and go (TUG)
30 Second STS Test	preoperative appointment and once again at their 2 and 6 weeks postoperatively	30 second sit-to-stand tests
Length of the Hospitalization	Daily up to 2 days while hospitalized	Length of time the patient is Hospitalized after their total knee replacement.
Bioimpedence	pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit	body composition before and after surgery to measure swelling. Lower numbers represent more swelling.
PONV (Post-operative Nausea and Vomiting)	Daily up to 2 days while hospitalized	patients will be asked about Nausea: None, Mild, Moderate or Severe