Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

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

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.

Study Overview

• Status: Recruiting
• Conditions: Length of Stay; Same-day Discharge
• Intervention / Treatment: Dietary supplement: Complex Carbohydrate Drink

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.

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Rodriguez, MD; Phone Number: 212-552-5829; Email: rodriguezjose@hss.edu
• Study Contact Backup: Name: Ricardo Torres-Ramirez, BS; Phone Number: 212-260-3763; Email: torresr@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Hospital for Special Surgery
      • Contact: Ricardo Torres, BS; Phone Number: 212-260-3763; Email: torresr@hss.edu
      • Sub-Investigator: Samuel Rodriguez, MD
      • Sub-Investigator: Alejandro Gonzalez Della Valle, MD
      • Sub-Investigator: Michael Ast, MD
      • Sub-Investigator: Stravos Memtsoudis, MD
      • Sub-Investigator: Ricardo Torres, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Complex Carbohydrate Drink; Patients will drink a complex carbohydrate drink 3 hours before surgery. Drink to be given at the preoperative holding area.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay in hours	Length of hospital stay in hours, assess by medical record.	From admission to discharge, up to 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Same day discharge rate	Percentage of patients discharged successfully the day of surgery.	Through study completion, an average of 3 months.
Number of physical therapy sessions attempted	Number of physical therapy sessions attempted, assess by medical record.	From admission to discharge, up to 1 week.
Total distance walked	Total distance walked during physical therapy attempts, assess by medical record.	From admission to discharge, up to 1 week.
Number of stairs climbed	Number of stairs climbed during physical therapy attempts, assess by medical record.	From admission to discharge, up to 1 week.
Orthostatic hypotension episodes	Orthostatic hypotension episodes during physical therapy attempts, assess by medical record.	During physical therapy attempts, from admission to discharge.
HOOS JR Score	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.	The morning of surgery and at the first post-operative visit, up to 4 months post-op.
KOOS JR Score	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.	The morning of surgery and at the first post-operative visit, up to 4 months post-op.
VR-12 Score	The VR-12 is a 12-item self-reported questionnaire that assesses the patient physical and mental quality of life.	The morning of surgery and at the first post-operative visit, up to 4 months post-op.
Urine osmolality	Urine osmolality taken preoperatively, assess by medical record.	Measured preoperatively the morning of surgery.
Urine specific gravity	Urine specific gravity preoperatively, assess by medical record.	Measured preoperatively the morning of surgery.
In-house costs	In-house costs taking into account cost of complex carbohydrate drink vs previously published costs savings per night of stay.	From admission to discharge, up to 1 week.

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Jose A Rodriguez, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Estimated): January 24, 2024
• Study Completion (Estimated): January 24, 2024

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Carbohydrate Drink; Perioperative Fluids; Same-day Discharge; Total Joint Arthroplasty; Same-day total hip arthroplasty; Same-day total knee arthroplasty
• Other Study ID Numbers: 2020-2597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No