Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04003350
Enrollment
216
Registered
2019-07-01
Start date
2017-12-21
Completion date
2019-03-15
Last updated
2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee

Brief 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.

Interventions

DRUGOxycodone

Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)

DRUGTramadol

Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)

Tylenol 1000 mg: take as needed every 8 hours

DRUGMeloxicam

Meloxicam 15 mg as need once per day

DRUGGabapentin

•Gabapentin 200 mg with morning and evening Tylenol dose

Metaxalone 800mg TID

Esomeprazole 20mg daily

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis. * ASA I - III * Spinal anesthesia * All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases * Male and Female over 18 who are willing and able to provide informed consent

Exclusion criteria

* Opioid use within 3 months preoperatively * Inability to take the protocol medications * Anticoagulant other than aspirin * Contraindication to regional anesthesia * Non-english speaking * ASA IV or greater * Psychiatric or cognitive disorders * Allergy/contraindications to protocol medications. * Renal insufficiency with Cr \> 2.0 or hepatic failure * General anesthesia * Sensory/motor disorder involving the operative limb

Design outcomes

Primary

MeasureTime frameDescription
Post-operative painPostsurgery days 1-30Measured via Visual Analog scale (0-100mm)
Opioid related side effectspost-surgery days 1-30Severity measured via Visual Analog scale (0-100mm)

Secondary

MeasureTime frameDescription
opioid consumptionpost-surgery weeks 1-4morphine milligram equivalent
number of opioid refillspost-surgery weeks 1-4number of times subjects asked to have an opioid prescription refilled during post-operative period
90 day complicationspost-surgery 90 dayscollection of all post-operative medical complications within the first 90 days after surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026