Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

NCT ID: NCT05520593

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Same-day Discharge Length of Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Complex Carbohydrate Drink Group

The patients will drink a 400ml drink that contains 50g of complex carbohydrates, 3 hours prior to the surgery. The drink will be given once at the preoperative holding area. Patients are not allowed to eat solid foods after 12am the morning of surgery and can only drink clear fluids up to 3 hours prior to the surgery.

Group Type EXPERIMENTAL

Complex Carbohydrate Drink

Intervention Type DIETARY_SUPPLEMENT

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

No-Complex Carbohydrate Drink Group

These patients will follow normal institutional preoperative fluid management guidelines, this consist of no solid foods after 12am the morning of surgery. Patients are allowed to drink clear liquids (water, clear fruit juices, coffee) from 12am the morning of surgery up to 3 hours prior to the surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Complex Carbohydrate Drink

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Jose Rodriguez

Professor of Clinical Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose A Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jose Rodriguez, MD

Role: CONTACT

212-552-5829

Ricardo Torres-Ramirez, BS

Role: CONTACT

212-260-3763

Facility Contacts

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Ricardo Torres, BS

Role: primary

2122603763

Other Identifiers

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2020-2597

Identifier Type: -

Identifier Source: org_study_id

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