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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Arthritis Knee Postoperative Nausea Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm B: Oral Dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

4 mg bid for 4 days

Arm A: Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral placebo

Interventions

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Dexamethasone

4 mg bid for 4 days

Intervention Type DRUG

Placebo

oral placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No