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Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05520593
Enrollment
312
Registered
2022-08-30
Start date
2022-11-07
Completion date
2027-01-01
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Length of Stay, Same-day Discharge

Keywords

Carbohydrate Drink, Perioperative Fluids, Same-day Discharge, Total Joint Arthroplasty, Nausea, Vomiting, Same-day total hip arthroplasty, Same-day total knee arthroplasty

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.

Interventions

DIETARY_SUPPLEMENTComplex Carbohydrate Drink

Patients will drink a complex carbohydrate drink 3 hours before surgery. Drink to be given at the preoperative holding area.

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stay in hoursFrom admission to discharge, up to 1 weekLength of hospital stay in hours, assess by medical record.

Secondary

MeasureTime frameDescription
Same day discharge rateThrough study completion, an average of 3 months.Percentage of patients discharged successfully the day of surgery.
Number of physical therapy sessions attemptedFrom admission to discharge, up to 1 week.Number of physical therapy sessions attempted, assess by medical record.
Total distance walkedFrom admission to discharge, up to 1 week.Total distance walked during physical therapy attempts, assess by medical record.
Number of stairs climbedFrom admission to discharge, up to 1 week.Number of stairs climbed during physical therapy attempts, assess by medical record.
Orthostatic hypotension episodesDuring physical therapy attempts, from admission to discharge.Orthostatic hypotension episodes during physical therapy attempts, assess by medical record.
HOOS JR ScoreThe morning of surgery and at the first post-operative visit, up to 4 months post-op.This is a 6-item questionnaire that assesses patient-reported hip pain and function. Score ranges from 0-100, with 100 representing the best possible score.
KOOS JR ScoreThe morning of surgery and at the first post-operative visit, up to 4 months post-op.This is a 6-item questionnaire that assesses patient reported knee pain and function. Score ranges from -100, with 100 representing the best score possible.
VR-12 ScoreThe morning of surgery and at the first post-operative visit, up to 4 months post-op.The VR-12 is a 12-item self-reported questionnaire that assesses the patient physical and mental quality of life.
Urine osmolalityMeasured preoperatively the morning of surgery.Urine osmolality taken preoperatively, assess by medical record.
Urine specific gravityMeasured preoperatively the morning of surgery.Urine specific gravity preoperatively, assess by medical record.
In-house costsFrom admission to discharge, up to 1 week.In-house costs taking into account cost of complex carbohydrate drink vs previously published costs savings per night of stay.

Countries

United States

Contacts

CONTACTJose Rodriguez, MD
rodriguezjose@hss.edu212-552-5829
CONTACTRicardo Torres-Ramirez, BS
torresr@hss.edu212-260-3763
PRINCIPAL_INVESTIGATORJose A Rodriguez, MD

Hospital for Special Surgery, New York

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026