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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04003350 on ClinicalTrials.gov