Arthroplasty, Replacement, Knee
Conditions
Keywords
Fluid Management
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
Interventions
OTHERPre Operative Oral Fluids
Patients will be self hydrating prior to their total knee replacement.
Sponsors
Colorado Joint Replacement
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Change is patients weight from baseline at pre op to two weeks post op. | Patient Weight will be monitored |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 Second STS Test | preoperative appointment and once again at their 2 and 6 weeks postoperatively | 30 second sit-to-stand tests |
| 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. |
| 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 |
| 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. |
| 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) |
| 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. |
| 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 |
| Number of Participants With Thromboembolic Disease | Post Opeartive until the 6 week follow up appointment | The incidence of thromboembolic events will be recorded. |
| 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 |
| Time up and GO | preoperative appointment and once again at their 2 and 6 weeks postoperatively | timed up and go (TUG) |
| Length of the Hospitalization | Daily up to 2 days while hospitalized | Length of time the patient is Hospitalized after their total knee replacement. |
| 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. |
| PONV (Post-operative Nausea and Vomiting) | Daily up to 2 days while hospitalized | patients will be asked about Nausea: None, Mild, Moderate or Severe |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Daily up to 2 days while hospitalized | Blood Pressure (Diastolic/ Systolic) |
| Number of Participants With Adverse Events | While in hospital until the 6 week follow up appointment | episodes such as symptomatic hypotension (light-headedness, syncope), emesis, the need the IV fluid boluses, and other hospital and post-discharge events will be recorded |
| Total Number of Patients That Received Any Pressor Drugs | Up to Day 1 Post op | total amount of any pressor drugs given intraoperatively (e.g. Ephedrine and Phenylephrine) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional Fluid * 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. | 75 |
| Oral Fluid * 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.
Pre Operative Oral Fluids: Patients will be self hydrating prior to their total knee replacement. | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | Traditional Fluid | Oral Fluid | Total |
|---|---|---|---|
| Age, Continuous | 61.2 Years STANDARD_DEVIATION 7.5 | 60.9 Years STANDARD_DEVIATION 6.8 | 61 Years STANDARD_DEVIATION 7.2 |
| BMI | 28.5 kg/m^2 (BMI) STANDARD_DEVIATION 4.9 | 28.1 kg/m^2 (BMI) STANDARD_DEVIATION 4.2 | 28.3 kg/m^2 (BMI) STANDARD_DEVIATION 4.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 75 participants | 75 participants | 150 participants |
| Sex: Female, Male Female | 44 Participants | 42 Participants | 86 Participants |
| Sex: Female, Male Male | 31 Participants | 33 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 65 |
| other Total, other adverse events | 0 / 65 | 0 / 65 |
| serious Total, serious adverse events | 1 / 65 | 0 / 65 |
Outcome results
Primary
Body Weight
Patient Weight will be monitored
Time frame: Change is patients weight from baseline at pre op to two weeks post op.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Fluid | Body Weight | -1.9 pounds | Standard Deviation 4.4 |
| Oral Fluid | Body Weight | -1.6 pounds | Standard Deviation 4.4 |
Secondary
30 Second STS Test
30 second sit-to-stand tests
Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | 30 Second STS Test | Change from Preop to 2 weeks Post op | -5.3 sit-to-stand events | Standard Deviation 4 |
| Traditional Fluid | 30 Second STS Test | Change from Preop to 6 weeks Post op | -0.4 sit-to-stand events | Standard Deviation 4.1 |
| Oral Fluid | 30 Second STS Test | Change from Preop to 2 weeks Post op | -4.4 sit-to-stand events | Standard Deviation 4.6 |
| Oral Fluid | 30 Second STS Test | Change from Preop to 6 weeks Post op | 0.3 sit-to-stand events | Standard Deviation 3 |
Secondary
Bioimpedence
body composition before and after surgery to measure swelling. Lower numbers represent more swelling.
Time frame: pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Bioimpedence | Change from Preop to Post Op Day1 | -17.8 ohms | Standard Deviation 30.3 |
| Traditional Fluid | Bioimpedence | Change from Preop to 2 weeks post op | -41.4 ohms | Standard Deviation 34.2 |
| Traditional Fluid | Bioimpedence | Change from Preop to 6 weeks post op | -30.9 ohms | Standard Deviation 25.6 |
| Oral Fluid | Bioimpedence | Change from Preop to Post Op Day1 | 4.2 ohms | Standard Deviation 29.7 |
| Oral Fluid | Bioimpedence | Change from Preop to 2 weeks post op | -38.5 ohms | Standard Deviation 45.7 |
| Oral Fluid | Bioimpedence | Change from Preop to 6 weeks post op | -31.0 ohms | Standard Deviation 31.4 |
Secondary
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)
Time frame: Post Op Day 1, 2 Weeks and 6 Weeks Post Op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Knee Range of Motion | Post Op Day 1 | -30.5 degrees | Standard Deviation 18.5 |
| Traditional Fluid | Knee Range of Motion | 2 Weeks Post Op | -27.9 degrees | Standard Deviation 17.5 |
| Traditional Fluid | Knee Range of Motion | 6 Weeks Post OP | -7.7 degrees | Standard Deviation 17 |
| Oral Fluid | Knee Range of Motion | Post Op Day 1 | -26.7 degrees | Standard Deviation 16 |
| Oral Fluid | Knee Range of Motion | 2 Weeks Post Op | -25.5 degrees | Standard Deviation 16.5 |
| Oral Fluid | Knee Range of Motion | 6 Weeks Post OP | -4.8 degrees | Standard Deviation 13.2 |
Secondary
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.
Time frame: Post op Day 1, 2 weeks and 6 weeks Post Op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (10 cm suprapatellar) Post Op day 1 | 2.5 inches | Standard Deviation 3 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (10 cm suprapatellar) 2 weeks post op | 0.9 inches | Standard Deviation 3 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (10 cm suprapatellar) 6 weeks post op | 0.00 inches | Standard Deviation 2.6 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (5 cm suprapatellar) Post Op day 1 | 4.1 inches | Standard Deviation 2.4 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (5 cm suprapatellar) 2 weeks post op | 2.0 inches | Standard Deviation 2.3 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (5 cm suprapatellar) 6 weeks post op | 0.9 inches | Standard Deviation 1.9 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (Midpatellar) Post Op day 1 | 4.6 inches | Standard Deviation 2.2 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (Midpatellar) 2 weeks post op | 2.2 inches | Standard Deviation 2.3 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (Midpatellar) 6 weeks post op | 1.3 inches | Standard Deviation 1.6 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (10 cm inferior patella) Post Op day 1 | 2.7 inches | Standard Deviation 2.7 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (10 cm inferior patella) 2 weeks post op | 0.8 inches | Standard Deviation 2.1 |
| Traditional Fluid | Leg Anthropometric (Girth) Measurements | (10 cm inferior patella) 6 weeks post op | -0.2 inches | Standard Deviation 1.3 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (10 cm inferior patella) 2 weeks post op | 0.9 inches | Standard Deviation 2.3 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (10 cm suprapatellar) Post Op day 1 | 2.1 inches | Standard Deviation 3.1 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (Midpatellar) Post Op day 1 | 4.1 inches | Standard Deviation 2.6 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (10 cm suprapatellar) 2 weeks post op | 1.6 inches | Standard Deviation 4 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (10 cm inferior patella) Post Op day 1 | 1.5 inches | Standard Deviation 4.6 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (10 cm suprapatellar) 6 weeks post op | 0.00 inches | Standard Deviation 3.3 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (Midpatellar) 2 weeks post op | 3.0 inches | Standard Deviation 2 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (5 cm suprapatellar) Post Op day 1 | 4.0 inches | Standard Deviation 2.6 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (10 cm inferior patella) 6 weeks post op | 0.1 inches | Standard Deviation 1.5 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (5 cm suprapatellar) 2 weeks post op | 2.8 inches | Standard Deviation 2.6 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (Midpatellar) 6 weeks post op | 1.3 inches | Standard Deviation 2 |
| Oral Fluid | Leg Anthropometric (Girth) Measurements | (5 cm suprapatellar) 6 weeks post op | 1.0 inches | Standard Deviation 2.2 |
Secondary
Length of the Hospitalization
Length of time the patient is Hospitalized after their total knee replacement.
Time frame: Daily up to 2 days while hospitalized
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Traditional Fluid | Length of the Hospitalization | 1 Day | 56 Participants |
| Traditional Fluid | Length of the Hospitalization | 2 Days | 9 Participants |
| Oral Fluid | Length of the Hospitalization | 1 Day | 63 Participants |
| Oral Fluid | Length of the Hospitalization | 2 Days | 2 Participants |
Secondary
Number of Participants With Off Wound Complications Post Operative
incidence of wound infection and wound drainage will be assessed and recorded
Time frame: Up to 6 weeks Post OP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Fluid | Number of Participants With Off Wound Complications Post Operative | 0 Participants |
| Oral Fluid | Number of Participants With Off Wound Complications Post Operative | 0 Participants |
Secondary
Number of Participants With Requiring Transfusions
Post Operative/Intra Operative Transfusions
Time frame: intra operative, Post Op Day #1 or #2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Fluid | Number of Participants With Requiring Transfusions | 0 Participants |
| Oral Fluid | Number of Participants With Requiring Transfusions | 1 Participants |
Secondary
Number of Participants With Thromboembolic Disease
The incidence of thromboembolic events will be recorded.
Time frame: Post Opeartive until the 6 week follow up appointment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Fluid | Number of Participants With Thromboembolic Disease | 1 Participants |
| Oral Fluid | Number of Participants With Thromboembolic Disease | 0 Participants |
Secondary
Number of Patients Re-admitted Post TKA
Number of patients re-admitted post TKA
Time frame: up to 6 weeks post op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Fluid | Number of Patients Re-admitted Post TKA | 1 Participants |
| Oral Fluid | Number of Patients Re-admitted Post TKA | 0 Participants |
Secondary
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.
Time frame: pre-operatively as well as at their 2 week and 6 week follow up appointments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) | Change is score from pre op to 2 weeks | -1.6 score on a scale | Standard Deviation 16.2 |
| Traditional Fluid | Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) | Change is score from pre op to 6 weeks | 9.4 score on a scale | Standard Deviation 14.5 |
| Oral Fluid | Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) | Change is score from pre op to 2 weeks | 3.1 score on a scale | Standard Deviation 13.8 |
| Oral Fluid | Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS) | Change is score from pre op to 6 weeks | 12.3 score on a scale | Standard Deviation 14.1 |
Secondary
Patient Reported Outcomes - Knee Society Score(KSS)
Knee Society Score(KSS), the total scores range from 0 - 200, 200 being the best.
Time frame: pre-operatively as well as at their 2 week and 6 week follow up appointments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Patient Reported Outcomes - Knee Society Score(KSS) | Change from Preop to 2 weeks Post op | -14.6 score on a scale | Standard Deviation 39.9 |
| Traditional Fluid | Patient Reported Outcomes - Knee Society Score(KSS) | Change from pre op to 6 weeks | 31.9 score on a scale | Standard Deviation 36.3 |
| Oral Fluid | Patient Reported Outcomes - Knee Society Score(KSS) | Change from Preop to 2 weeks Post op | -0.2 score on a scale | Standard Deviation 36.2 |
| Oral Fluid | Patient Reported Outcomes - Knee Society Score(KSS) | Change from pre op to 6 weeks | 40.5 score on a scale | Standard Deviation 35.4 |
Secondary
PONV (Post-operative Nausea and Vomiting)
patients will be asked about Nausea: None, Mild, Moderate or Severe
Time frame: Daily up to 2 days while hospitalized
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Traditional Fluid | PONV (Post-operative Nausea and Vomiting) | None | 51 Participants |
| Traditional Fluid | PONV (Post-operative Nausea and Vomiting) | Mild | 9 Participants |
| Traditional Fluid | PONV (Post-operative Nausea and Vomiting) | Moderat | 3 Participants |
| Traditional Fluid | PONV (Post-operative Nausea and Vomiting) | Severe | 2 Participants |
| Oral Fluid | PONV (Post-operative Nausea and Vomiting) | Severe | 4 Participants |
| Oral Fluid | PONV (Post-operative Nausea and Vomiting) | None | 46 Participants |
| Oral Fluid | PONV (Post-operative Nausea and Vomiting) | Moderat | 3 Participants |
| Oral Fluid | PONV (Post-operative Nausea and Vomiting) | Mild | 12 Participants |
Secondary
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.
Time frame: 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)
Population: Some of the patients did not complete their pain log for the study, which is why the numbers are different below.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 1 | 4.3 units on a scale | Standard Deviation 1.6 |
| Traditional Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Post Op Day 1 | 2.6 units on a scale | Standard Deviation 1.4 |
| Traditional Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Post Op Day 2 | 4.4 units on a scale | Standard Deviation 1.5 |
| Traditional Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 2 | 3.6 units on a scale | Standard Deviation 1.8 |
| Traditional Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 3 | 3.0 units on a scale | Standard Deviation 1.7 |
| Traditional Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 4 | 2.7 units on a scale | Standard Deviation 1.6 |
| Oral Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 3 | 3.2 units on a scale | Standard Deviation 1.7 |
| Oral Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 2 | 3.4 units on a scale | Standard Deviation 1.5 |
| Oral Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Post Op Day 1 | 2.3 units on a scale | Standard Deviation 1.4 |
| Oral Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 4 | 2.6 units on a scale | Standard Deviation 1.4 |
| Oral Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Post Op Day 2 | 4.5 units on a scale | Standard Deviation 1.6 |
| Oral Fluid | Postoperative Pain Assessment Using Visual Analog Scale | Average Week 1 | 4.1 units on a scale | Standard Deviation 1.6 |
Secondary
Quadriceps Strength Measure With a Handheld Dynamometer
The strength testing will be calculated using a handheld dynamometer
Time frame: Post Op day 1, 2 Week and 6 Week Post OP
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Quadriceps Strength Measure With a Handheld Dynamometer | Change from Preop to Post Op Day1 | -10.4 KG | Standard Deviation 7.6 |
| Traditional Fluid | Quadriceps Strength Measure With a Handheld Dynamometer | Change from Preop to 2 weeks post op | -9.0 KG | Standard Deviation 6.5 |
| Traditional Fluid | Quadriceps Strength Measure With a Handheld Dynamometer | Change from Preop to 6 weeks post op | -3.2 KG | Standard Deviation 5.8 |
| Oral Fluid | Quadriceps Strength Measure With a Handheld Dynamometer | Change from Preop to Post Op Day1 | -11.2 KG | Standard Deviation 7.1 |
| Oral Fluid | Quadriceps Strength Measure With a Handheld Dynamometer | Change from Preop to 2 weeks post op | -9.6 KG | Standard Deviation 7.2 |
| Oral Fluid | Quadriceps Strength Measure With a Handheld Dynamometer | Change from Preop to 6 weeks post op | -3.8 KG | Standard Deviation 6.5 |
Secondary
Time up and GO
timed up and go (TUG)
Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Time up and GO | Change from Preop to 2 weeks Post op | 4.4 Seconds | Standard Deviation 4.8 |
| Traditional Fluid | Time up and GO | Change from Preop to 6 weeks Post op | -4.7 Seconds | Standard Deviation 3.5 |
| Oral Fluid | Time up and GO | Change from Preop to 2 weeks Post op | 3.3 Seconds | Standard Deviation 3.7 |
| Oral Fluid | Time up and GO | Change from Preop to 6 weeks Post op | -4.0 Seconds | Standard Deviation 3.9 |
Secondary
Total IV Fluids Received
Total amount of IV fluids that the patients received while in the hospital
Time frame: Duration of IV intervention, up to 2 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Traditional Fluid | Total IV Fluids Received | 3895 ML |
| Oral Fluid | Total IV Fluids Received | 350 ML |
Secondary
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
Time frame: 2 week and 6 week follow up appointments
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Veterans Rand -12 | Change from Preop - 2 Weeks Post Op Mental Score | -4.7 score on a scale | Standard Deviation 12.2 |
| Traditional Fluid | Veterans Rand -12 | Change from Preop - 2 Weeks PostOp Physical Score | -8.3 score on a scale | Standard Deviation 10 |
| Traditional Fluid | Veterans Rand -12 | Change from Pre op - 6 Weeks Post Op Mental Score | -2.5 score on a scale | Standard Deviation 11.5 |
| Traditional Fluid | Veterans Rand -12 | Change from Preop - 6 Weeks PostOp Physical Score | -0.5 score on a scale | Standard Deviation 10.6 |
| Oral Fluid | Veterans Rand -12 | Change from Preop - 6 Weeks PostOp Physical Score | 2.2 score on a scale | Standard Deviation 12.2 |
| Oral Fluid | Veterans Rand -12 | Change from Preop - 2 Weeks Post Op Mental Score | -1.2 score on a scale | Standard Deviation 10.4 |
| Oral Fluid | Veterans Rand -12 | Change from Pre op - 6 Weeks Post Op Mental Score | -3.2 score on a scale | Standard Deviation 11.4 |
| Oral Fluid | Veterans Rand -12 | Change from Preop - 2 Weeks PostOp Physical Score | -4.5 score on a scale | Standard Deviation 11.2 |
Other Pre-specified
Blood Pressure
Blood Pressure (Diastolic/ Systolic)
Time frame: Daily up to 2 days while hospitalized
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to Recovery Room (Systolic) | 21.5 Change in mmHg | Standard Deviation 15.9 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to Recovery Room (Diastolic) | 18.4 Change in mmHg | Standard Deviation 12.2 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to Arrival on 4th floor (Systolic) | 10.6 Change in mmHg | Standard Deviation 12.8 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to Arrival on 4th floor (Diastolic) | 10.5 Change in mmHg | Standard Deviation 10.3 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to 08:00 on floor (Systolic) | 17.0 Change in mmHg | Standard Deviation 12.9 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to 08:00 on floor (Diastolic) | 16.5 Change in mmHg | Standard Deviation 9.3 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to 16:00 on floor (Systolic) | 20.9 Change in mmHg | Standard Deviation 14 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to 16:00 on floor (Diastolic) | 16.3 Change in mmHg | Standard Deviation 11.2 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to 24:00 on floor (Systolic) | 12.5 Change in mmHg | Standard Deviation 14.7 |
| Traditional Fluid | Blood Pressure | Change in mmHg Pre Op to 24:00 on floor (Diastolic) | 14.6 Change in mmHg | Standard Deviation 9.9 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to 16:00 on floor (Diastolic) | 18.7 Change in mmHg | Standard Deviation 11.8 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to Recovery Room (Systolic) | 26.0 Change in mmHg | Standard Deviation 16.7 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to 08:00 on floor (Diastolic) | 16.0 Change in mmHg | Standard Deviation 9.6 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to Recovery Room (Diastolic) | 17.2 Change in mmHg | Standard Deviation 11.9 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to 24:00 on floor (Diastolic) | 11.1 Change in mmHg | Standard Deviation 10.2 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to Arrival on 4th floor (Systolic) | 19.4 Change in mmHg | Standard Deviation 13.5 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to 16:00 on floor (Systolic) | 25.8 Change in mmHg | Standard Deviation 13.8 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to Arrival on 4th floor (Diastolic) | 9.3 Change in mmHg | Standard Deviation 10.8 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to 24:00 on floor (Systolic) | 12.5 Change in mmHg | Standard Deviation 12.9 |
| Oral Fluid | Blood Pressure | Change in mmHg Pre Op to 08:00 on floor (Systolic) | 23.4 Change in mmHg | Standard Deviation 13.3 |
Other Pre-specified
Number of Participants With Adverse Events
episodes such as symptomatic hypotension (light-headedness, syncope), emesis, the need the IV fluid boluses, and other hospital and post-discharge events will be recorded
Time frame: While in hospital until the 6 week follow up appointment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Fluid | Number of Participants With Adverse Events | 3 Participants |
| Oral Fluid | Number of Participants With Adverse Events | 2 Participants |
Other Pre-specified
Total Number of Patients That Received Any Pressor Drugs
total amount of any pressor drugs given intraoperatively (e.g. Ephedrine and Phenylephrine)
Time frame: Up to Day 1 Post op
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Traditional Fluid | Total Number of Patients That Received Any Pressor Drugs | Yes | 23 Participants |
| Traditional Fluid | Total Number of Patients That Received Any Pressor Drugs | No | 42 Participants |
| Oral Fluid | Total Number of Patients That Received Any Pressor Drugs | Yes | 22 Participants |
| Oral Fluid | Total Number of Patients That Received Any Pressor Drugs | No | 43 Participants |