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

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ClinicalTrials.gov Identifier: NCT04003350
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Drug: Oxycodone Drug: Tramadol Drug: Tylenol Drug: Meloxicam Drug: Gabapentin Drug: Metaxalone Drug: Esomeprazole 20mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : November 26, 2018
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003350


Locations
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United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Rothman Institute Orthopaedics

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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04003350     History of Changes
Other Study ID Numbers: 2019MAUSTKA
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Oxycodone
Tramadol
Analgesics
Gabapentin
Meloxicam
Acetaminophen
Metaxalone
Esomeprazole
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Anti-Ulcer Agents