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OpenTrials
Completed

NCT Number: NCT04003350

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

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.

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Key information

Conditions

Osteo Arthritis Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

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

Tramadol

Drug

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

Tylenol

Drug

Tylenol 1000 mg: take as needed every 8 hours

Meloxicam

Drug

Meloxicam 15 mg as need once per day

Gabapentin

Drug

•Gabapentin 200 mg with morning and evening Tylenol dose

Metaxalone

Drug

Metaxalone 800mg TID

Esomeprazole 20mg

Drug

Esomeprazole 20mg daily

Primary outcomes

  1. Post-operative pain

    Time frame: Postsurgery days 1-30

    Measured via Visual Analog scale (0-100mm)

  2. Opioid related side effects

    Time frame: post-surgery days 1-30

    Severity measured via Visual Analog scale (0-100mm)

Secondary outcomes

  1. opioid consumption

    Time frame: post-surgery weeks 1-4

    morphine milligram equivalent

  2. opioid consumption

    Time frame: post-surgery weeks 1-4

    number of pills consumed

  3. 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

  4. 90 day complications

    Time frame: post-surgery 90 days

    collection of all post-operative medical complications within the first 90 days after surgery

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 1, 2019
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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