Trials / Completed
CompletedNCT04003350
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 216 (actual)
- Sponsor
- Rothman Institute Orthopaedics · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-12-21
- Primary completion
- 2018-11-26
- Completion
- 2019-03-15
- First posted
- 2019-07-01
- Last updated
- 2019-07-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04003350. Inclusion in this directory is not an endorsement.