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Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358888
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE November 27, 2017
First Posted Date  ICMJE December 2, 2017
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE June 5, 2017
Actual Primary Completion Date January 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • total opioid consumption [ Time Frame: total consumption calcuated from surgery date through 30 days post-op ]
  • Pain [ Time Frame: 30 days post-operative ]
    Pain as reported by Visual Analog Scale
Original Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
total opioid consumption [ Time Frame: total consumption calcuated from surgery date through 30 days post-op ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
Official Title  ICMJE Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
Brief Summary This is a prospective, three-arm, comparative study with a provider-crossover design. The first arm will comprise the standard of care pain regimen after discharge, which comprises PRN oxycodone, tramadol, and acetaminophen. The second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use on an as needed basis. The third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption. However, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Osteoarthritis, Hip
Intervention  ICMJE
  • Drug: Multi-modal with as needed opioids
    Multi-modal with as needed oxycodone and tramadol provided for break-through pain
  • Drug: Multi-modal with one week of opioids offered
    Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only
  • Drug: Standard of Care
    This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin
Study Arms  ICMJE
  • Active Comparator: Standard of Care
    Intervention: Drug: Standard of Care
  • Active Comparator: Multi-modal with as needed opioids
    Intervention: Drug: Multi-modal with as needed opioids
  • Active Comparator: Multi-modal with one week of opioids offered
    Intervention: Drug: Multi-modal with one week of opioids offered
Publications * Fleischman AN, Tarabichi M, Foltz C, Makar G, Hozack WJ, Austin MS, Chen AF; Opioid Prescription in Orthopedic Surgery after Discharge Research Group. Cluster-Randomized Trial of Opiate-Sparing Analgesia after Discharge from Elective Hip Surgery. J Am Coll Surg. 2019 Oct;229(4):335-345.e5. doi: 10.1016/j.jamcollsurg.2019.05.026. Epub 2019 Jun 5.

*   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: November 27, 2017)
228
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date January 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis.
  • ASA I - III
  • Spinal anesthesia
  • Male and Female over 18 who are willing and able to provide informed consent

Exclusion Criteria:

  • Opioid use within 3 months prior to surgery
  • General anesthesia
  • Non-english speaking
  • ASA IV or greater
  • Allergy/contraindications to protocol medications
  • Renal insufficiency with Cr > 2.0 or hepatic failure
  • Sensory/motor disorder involving the operative limb
  • Planned or unplanned discharge to rehab
  • Length of stay >3 days
  • Revision or conversion THA
  • Cigarette smokers
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 NCT03358888
Other Study ID Numbers  ICMJE 2017- Chen
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 January 2019

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