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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04432259
• Other study ID #: 13565
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2020
• Est. completion date: December 2022

Study information

• Verified date: June 2020
• Source: Henry Ford Health System
• Contact: Jonathan Shaw, M.D.
• Phone: 414-405-8544
• Email: jshaw5[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arthritis Knee
• Nausea
• Pain, Postoperative
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
4 mg bid for 4 days
• Placebo
oral placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	Postoperative pain will be collected via visual analog scores	3 weeks following surgery
Primary	Postoperative Nausea	Postoperative Nausea will be collected via visual analog scores	3 weeks following surgery
Primary	Opioid Consumption	Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded	6 months
Primary	Antiemetic Consumption		6 months
Primary	Episodes of Nausea		3 weeks
Secondary	Postoperative complications	Incidence of surgical site infection, acute prosthetic joint infection	6 months
Secondary	Patient-reported outcome scores (PROMS)		6 months
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)		6 months