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

June 27, 2019 updated by: Rothman Institute Orthopaedics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19148
        • Rothman Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Opioid Regimen

Weeks 1-4

  • Oxycodone 5 mg PRN q4h (30 tablets)
  • Tramadol 50 mg PRN q6h (30 tablets)
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)
EXPERIMENTAL: Multimodal pain regimen with PRN opioids

Weeks 1-4

  • Tylenol 1000 mg q8h (standing)
  • Meloxicam 15 mg qD (standing).
  • Gabapentin 200 mg BID (with morning and evening Tylenol dose)
  • Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
  • Esomeprazole 20mg daily if not already on another H2 blocker or PPI
  • Oxycodone 5 mg PRN q4h (30 tablets)
  • Tramadol 50 mg PRN q6h (30 tablets)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: Postsurgery days 1-30
Measured via Visual Analog scale (0-100mm)
Postsurgery days 1-30
Opioid related side effects
Time Frame: post-surgery days 1-30
Severity measured via Visual Analog scale (0-100mm)
post-surgery days 1-30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: post-surgery weeks 1-4
morphine milligram equivalent
post-surgery weeks 1-4
opioid consumption
Time Frame: post-surgery weeks 1-4
number of pills consumed
post-surgery weeks 1-4
number of opioid refills
Time Frame: post-surgery weeks 1-4
number of times subjects asked to have an opioid prescription refilled during post-operative period
post-surgery weeks 1-4
90 day complications
Time Frame: post-surgery 90 days
collection of all post-operative medical complications within the first 90 days after surgery
post-surgery 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2017

Primary Completion (ACTUAL)

November 26, 2018

Study Completion (ACTUAL)

March 15, 2019

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (ACTUAL)

July 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019MAUSTKA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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