Clinical trial NCT05520593: Preoperative Oral Hydration in the Ambulatory Arthroplasty Population
Official title: Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Same-day Discharge
Length of Stay
Keywords: Carbohydrate Drink
Perioperative Fluids
Same-day Discharge
Total Joint Arthroplasty
Nausea
Vomiting
Same-day total hip arthroplasty
Same-day total knee arthroplasty
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.

Detailed description: The way total joint arthroplasty is practiced continues to evolve as CMS removed total hip arthroplasty (THA) from the inpatient-only list and added total knee arthroplasty (TKA) to the ASC Covered Surgical Procedures List (CPL) in 2020. Thus, surgeons must find subtle interventions that improve patient outcomes while minimizing the risk of adverse reactions. Current literature has not assessed the influence of preoperative hydration, using a complex carbohydrate drink, on the same-day discharge rate and causes for failure to launch. Considering variabilities in perioperative fluid management leading to postoperative nausea, vomiting, and dizziness, the investigators seek to reduce the incidence of these events by optimizing patients using a preoperative oral hydration protocol, reducing the length of stay, and improving same-day discharge rates.

Eligibility criteria: Inclusion Criteria:

* Candidates for ambulatory total knee arthroplasty
* Candidates for ambulatory total hip arthroplasty
* Candidates for ambulatory revision knee arthroplasty (liner exchange only)
* Candidates for ambulatory revision hip arthroplasty (liner exchange only)
* Case scheduled before noon (12 pm)
* Patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge

Exclusion Criteria:

* BMI less than 18.5 or greater than 37.0
* Patients with diabetes, chronic kidney disease, clotting disorders, or neurological conditions preventing control of the affected limb.
* Pregnant women
* Patients scheduled as ambulatory due to insurance mandates
* Patients with a history of active ischemia, significant valvular disease, significant arrhythmias, obstructive sleep apnea as per Hospital for Special Surgery guidelines, chronic opioid dependence (chronic daily opioid use for six or more months), and glomerular filtration rate \< 60ml/min.

Primary outcomes:
measure: Length of hospital stay in hours
timeFrame: From admission to discharge, up to 1 week
Secondary outcomes:
measure: Same day discharge rate
timeFrame: Through study completion, an average of 3 months.
measure: Number of physical therapy sessions attempted
timeFrame: From admission to discharge, up to 1 week.
measure: Total distance walked
timeFrame: From admission to discharge, up to 1 week.
measure: Number of stairs climbed
timeFrame: From admission to discharge, up to 1 week.
measure: Orthostatic hypotension episodes
timeFrame: During physical therapy attempts, from admission to discharge.
measure: HOOS JR Score
timeFrame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
measure: KOOS JR Score
timeFrame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
measure: VR-12 Score
timeFrame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
measure: Urine osmolality
timeFrame: Measured preoperatively the morning of surgery.
measure: Urine specific gravity
timeFrame: Measured preoperatively the morning of surgery.
measure: In-house costs
timeFrame: From admission to discharge, up to 1 week.
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jose A Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: