Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty

NCT04432259 | Not Yet Recruiting Phase 4

• 1 other identifier: 13565
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.

Conditions

Arthritis Knee; Postoperative Nausea; Postoperative Pain

Outcome Measures

Primary Outcomes (5)

• Postoperative Pain

  Postoperative pain will be collected via visual analog scores

  3 weeks following surgery

• Postoperative Nausea

  Postoperative Nausea will be collected via visual analog scores

  3 weeks following surgery

• Opioid Consumption

  Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded

  6 months

• Antiemetic Consumption

  6 months

• Episodes of Nausea

  3 weeks

Secondary Outcomes (3)

• Postoperative complications

  6 months

• Patient-reported outcome scores (PROMS)

  6 months

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  6 months

Study Arms (2)

Arm B: Oral Dexamethasone

EXPERIMENTAL

Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days

Drug: Dexamethasone

Arm A: Placebo

PLACEBO COMPARATOR

Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days

Drug: Placebo

Interventions

Dexamethasone DRUG

4 mg bid for 4 days

Arm B: Oral Dexamethasone

Placebo DRUG

oral placebo

Arm A: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients age 18 and older who will be undergoing joint replacement

You may not qualify if:

• Patients with uncontrolled diabetes ( HbA1C, \>7.5%), impaired hepatic function (Child class, \>B), impaired renal failure (Glomerular filtration rate \<60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.

Sponsors & Collaborators

• Henry Ford Health System: lead

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jason Davis, M.D.

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Shaw, M.D.

CONTACT

414-405-8544; jshaw5@hfhs.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Model Details: Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: July 1, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 16, 2020

Record last verified: 2020-06