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

• Sponsor: Henry Ford Health System (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04432259
• Collaborator: (none)
• Enrollment: 300
• Arms: 2
• Anticipated Duration (Months): 29

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Arthritis Knee; Postoperative Nausea; Postoperative Pain	Drug: Dexamethasone; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty
• Anticipated Study Start Date: Jul 1, 2020
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm B: Oral Dexamethasone Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days	Drug: Dexamethasone; 4 mg bid for 4 days
Placebo Comparator: Arm A: Placebo Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days	Drug: Placebo; oral placebo

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain [3 weeks following surgery]

   Postoperative pain will be collected via visual analog scores

2. Postoperative Nausea [3 weeks following surgery]

   Postoperative Nausea will be collected via visual analog scores

3. Opioid Consumption [6 months]

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

4. Antiemetic Consumption [6 months]

5. Episodes of Nausea [3 weeks]

Secondary Outcome Measures

1. Postoperative complications [6 months]

   Incidence of surgical site infection, acute prosthetic joint infection

2. Patient-reported outcome scores (PROMS) [6 months]

3. Knee Injury and Osteoarthritis Outcome Score (KOOS) [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Henry Ford Health System

Investigators

• Principal Investigator: Jason Davis, M.D., Henry Ford Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan H. Shaw, Orthopaedic Surgeon, Henry Ford Health System
• ClinicalTrials.gov Identifier: NCT04432259
• Other Study ID Numbers: 13565
• First Posted: Jun 16, 2020
• Last Update Posted: Jun 16, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pain, Postoperative; Nausea; Postoperative Nausea and Vomiting; Dexamethasone

Study Results

No Results Posted as of Jun 16, 2020