Dexamethasone in Total Knee Arthroplasty

Sponsor

Rush University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05018091

Collaborator

(none)

429

Enrollment

Locations

Arms

18.1

Anticipated Duration (Months)

71.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the most efficacious and safest dexamethasone dose given intraoperatively during total knee arthroplasty that reduces postoperative opioid consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty	Drug: Dexamethasone 4mg Drug: Dexamethasone 8 Mg/mL Injectable Suspension Drug: Dexamethasone 16mg	Phase 4

Detailed Description

Study design: Prospective randomized controlled trial

Scientific Background: In contemporary total joint arthroplasty (TJA), multimodal anesthesia and analgesia is used to improve postoperative pain, reduce opioid consumption, and minimize complications after surgery such as postoperative nausea and vomiting.1-3 Multiple medications with varying mechanisms of action are used at different time points throughout the perioperative period to modulate different pain receptors. Corticosteroids are a medication commonly utilized intraoperatively as part of contemporary multimodal protocols.

Corticosteroids are frequently used in TJA due to their potent anti-inflammatory and anti-emetic properties. Several studies have demonstrated that corticosteroids reduce postoperative nausea and vomiting as well as postoperative pain and opioid consumption.4-6 However, the optimal medication, dose, and number of doses of corticosteroid that should be administered in the perioperative period remain unknown. In addition, it remains unclear if corticosteroids can be safely used in patients with diabetes mellitus or if corticosteroids increase the risk of postoperative complications such as periprosthetic joint infection. Thus, the purpose of our study is to determine the most efficacious and safest dose of corticosteroids that should be administered intraoperatively during TJA.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

429 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively

Actual Study Start Date :

Oct 28, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 4mg intravenous dexamethasone, administered shortly after induction of anesthesia	Drug: Dexamethasone 4mg 4mg intravenous dexamethasone, administered shortly after induction of anesthesia Other Names: Group 1
Active Comparator: Group 2 8mg intravenous dexamethasone, administered shortly after induction of anesthesia	Drug: Dexamethasone 8 Mg/mL Injectable Suspension 8mg intravenous dexamethasone, administered shortly after induction of anesthesia Other Names: Group 2
Active Comparator: Group 3 16mg intravenous dexamethasone, administered shortly after induction of anesthesia	Drug: Dexamethasone 16mg 16mg intravenous dexamethasone, administered shortly after induction of anesthesia Other Names: Group 3

Arm

Intervention/Treatment

Active Comparator: Group 1

4mg intravenous dexamethasone, administered shortly after induction of anesthesia

Drug: Dexamethasone 4mg

4mg intravenous dexamethasone, administered shortly after induction of anesthesia

Other Names:

Group 1

Active Comparator: Group 2

8mg intravenous dexamethasone, administered shortly after induction of anesthesia

Drug: Dexamethasone 8 Mg/mL Injectable Suspension

8mg intravenous dexamethasone, administered shortly after induction of anesthesia

Other Names:

Group 2

Active Comparator: Group 3

16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Drug: Dexamethasone 16mg

16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Other Names:

Group 3

Outcome Measures

Primary Outcome Measures

Opioid consumption [48-hours postoperative (after surgical intervention)]
48 hours of cumulative opioid consumption measured in oral morphine equivalents

Secondary Outcome Measures

Postoperative pain scores at rest and with activity [Immediately after surgical intervention (TKA) for days 1 through 7 after surgery]
Using daily Defense and Veterans Pain Rating scale to rate pain at rest and with activity
Postoperative nausea and vomiting [Immediately after surgical intervention (TKA) for days 1 through 7 after surgery. Using numeric rating scale.]
Using numeric rating scale, (1-10, where 10 is most nausea, causing vomiting followed by number of times participant vomited in 24-hour period).
Postoperative Blood glucose levels and insulin use [Immediately following surgical intervention until discharge from hospital (up to 30 days after surgery if still in hospital)]
check glucose levels in daily blood draws when inpatient at hospital, insulin if applicable
Length of stay [immediately following surgery (intervention), number of days spent in the hospital after surgery to discharge, up to 30 days after intervention]
Days inpatient at hospital after surgery
Sleeplessness/insomnia [Immediately after surgical intervention (TKA) for days 1 through 7 after surgery, recording 24 hour sleep patterns]
recorded by patient, daily sleep schedule
Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention [<30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery]
Readmission after surgery, infection, VTE, GI hemorrhage or any other complication that requires rehospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age > 18 years
Primary total knee arthroplasty
Patients staying at least one night in the hospital after surgery

Exclusion Criteria:

Same day discharge Age < 18 years Revision or partial total knee arthroplasty Corticosteroid use within 3 months prior to surgery Inflammatory arthritis Current systemic fungal infection Renal or liver failure Prior adverse reaction to corticosteroid Primary TKA requiring hardware removal

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shiley Center for Orthopaedic Research and Education at Scripps Clinic	La Jolla	California	United States	92037
2	University of California, San Francisco	San Francisco	California	United States	94158
3	Rush University medical Center	Chicago	Illinois	United States	60612
4	Washington University	Saint Louis	Missouri	United States	63110
5	NYU Langone Health	New York	New York	United States	10016
6	Columbia University Irving Medical Center	New York	New York	United States	10032