The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
NCT04003350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2019-07-01
Summary
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.
PURPOSE:
1. To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects.
2. To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.
Conditions
- Osteo Arthritis Knee
Interventions
- DRUG
-
Oxycodone
Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)
- DRUG
-
Tramadol
Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)
- DRUG
-
Tylenol
Tylenol 1000 mg: take as needed every 8 hours
- DRUG
-
Meloxicam
Meloxicam 15 mg as need once per day
- DRUG
-
Gabapentin
•Gabapentin 200 mg with morning and evening Tylenol dose
- DRUG
-
Metaxalone
Metaxalone 800mg TID
- DRUG
-
Esomeprazole 20mg
Esomeprazole 20mg daily
Sponsors & Collaborators
-
Rothman Institute Orthopaedics
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-21
- Primary Completion
- 2018-11-26
- Completion
- 2019-03-15
Countries
- United States
Study Locations
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