drugset / Trial / NCT04003350

The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty

NCT04003350

Completed 216 enrolled Rothman Institute Orthopaedics
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-12-21
Primary completion
2018-11-26
Completion
2019-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1000 mg
Subject Esomeprazole Small molecule 20 mg
Subject Gabapentin Small molecule 200 mg
Subject Meloxicam Small molecule 15 mg
Subject Metaxalone Small molecule 800 mg Oral
Background Oxycodone Other / unclassified 5 mg
Background Tramadol Other / unclassified 50 mg

Indications