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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

Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date July 1, 2019
Actual Study Start Date  ICMJE December 21, 2017
Actual Primary Completion Date November 26, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Post-operative pain [ Time Frame: Postsurgery days 1-30 ]
    Measured via Visual Analog scale (0-100mm)
  • Opioid related side effects [ Time Frame: post-surgery days 1-30 ]
    Severity measured via Visual Analog scale (0-100mm)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • opioid consumption [ Time Frame: post-surgery weeks 1-4 ]
    morphine milligram equivalent
  • opioid consumption [ Time Frame: post-surgery weeks 1-4 ]
    number of pills consumed
  • 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
  • 90 day complications [ Time Frame: post-surgery 90 days ]
    collection of all post-operative medical complications within the first 90 days after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
Official Title  ICMJE The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteo Arthritis Knee
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Opioid Regimen

    Weeks 1-4

    • Oxycodone 5 mg PRN q4h (30 tablets)
    • Tramadol 50 mg PRN q6h (30 tablets)
    Interventions:
    • Drug: Oxycodone
    • Drug: Tramadol
  • 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)
    Interventions:
    • Drug: Oxycodone
    • Drug: Tramadol
    • Drug: Tylenol
    • Drug: Meloxicam
    • Drug: Gabapentin
    • Drug: Metaxalone
    • Drug: Esomeprazole 20mg
Publications * Li WT, Bell KL, Yayac M, Barmann JA, Star AM, Austin MS. A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial. J Arthroplasty. 2021 Jan;36(1):164-172.e2. doi: 10.1016/j.arth.2020.07.060. Epub 2020 Jul 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2019)
216
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2019
Actual Primary Completion Date November 26, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003350
Other Study ID Numbers  ICMJE 2019MAUSTKA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP