Clinical Trials Directory

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

TypeNameDescription
DRUGOxycodonePatients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)
DRUGTramadolPatients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)
DRUGTylenolTylenol 1000 mg: take as needed every 8 hours
DRUGMeloxicamMeloxicam 15 mg as need once per day
DRUGGabapentin•Gabapentin 200 mg with morning and evening Tylenol dose
DRUGMetaxaloneMetaxalone 800mg TID
DRUGEsomeprazole 20mgEsomeprazole 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.