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

Phase 4

Not yet recruiting

• Conditions: Postoperative Nausea; Arthritis Knee; Postoperative Pain
• Interventions: Drug: Placebo; Drug: Dexamethasone

• Registration Number: NCT04432259
• Lead Sponsor: Henry Ford Health System

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2020-06
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16
• Study Start: 2020-07
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Placebo	Placebo	Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days
Arm B: Oral Dexamethasone	Dexamethasone	Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days

Primary Outcome Measures

Name	Time	Method
Postoperative Nausea	3 weeks following surgery	Postoperative Nausea will be collected via visual analog scores
Antiemetic Consumption	6 months
Opioid Consumption	6 months	Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded
Postoperative Pain	3 weeks following surgery	Postoperative pain will be collected via visual analog scores
Episodes of Nausea	3 weeks

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcome scores (PROMS)	6 months
Postoperative complications	6 months	Incidence of surgical site infection, acute prosthetic joint infection
Knee Injury and Osteoarthritis Outcome Score (KOOS)	6 months