Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To help curb the use of opioid medications following orthopedic surgery investigators have
      developed a new multi-modal pain pathway. Investigators aim to compare this regimen with and
      without the inclusion of opioid medications. This study will be performed in a randomized,
      double-blinded, placebo-controlled fashion in patients undergoing primary total knee or total
      hip arthroplasty. Investigators hypothesize that the opioid devoid pathway will show
      equivalent pain scores to the pathway that includes opioids while also having less
      constipation, nausea, and vomiting following surgery. If successful, this would create a
      dramatic decrease in opioid consumption following orthopedic surgery while still providing
      appropriate pain relief to patients.
    

Detailed description: 
      -  Aim 1 will be to compare the postoperative pain levels both in the hospital setting as
           well as daily for two weeks following discharge between patients in the opioid treatment
           group and those in the non-opioid treatment group. This will be performed with clinical
           exams while in the hospital and with phone surveys on discharge. Results will be
           recorded using the Visual Analog Scale for pain scores.

        -  Aim 2 will be to compare the overall morphine equivalents used during hospitalization
           between the opioid and non-opioid treatment groups. This will be calculated based on the
           amount of intravenous breakthrough narcotic pain medication used in the hospital setting
           (divided by the total number of post-surgery hospitalization hours to account for
           varying lengths of stay). Investigators will also measure the total number of opioid
           pills (these would be placebo pills for the non-opioid group) consumed during the first
           two weeks post-discharge, and the post-surgery day on which opioid pills were
           discontinued, and compare these outcomes between the opioid and non-opioid groups.

        -  Aim 3 will be to compare postoperative constipation, nausea, and vomiting between the
           two treatment groups. This will be assessed with daily clinical examinations while in
           the hospital and with daily phone surveys on discharge. Constipation will be recorded as
           presence or absence, while nausea and vomiting will be measured using the Postoperative
           Nausea and Vomiting Scale.

        -  Aim 4 will be to compare the length of post-surgery hospitalization between the two
           treatment groups.
    

Intervention name(s): Oxycodone; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): The primary endpoint will be pain scores, calculated by the Visual Analog Scale. This score will be collected daily during the hospital examination and by phone surveys for two weeks following discharge. Investigators hypothesize that the non-opioid pain regimen will provide equivalent relief as compared to the opioid regimen.; The primary endpoint will be pain scores, calculated by the Visual Analog Scale. This score will be collected daily during the hospital examination and by phone surveys for two weeks following discharge. Investigators hypothesize that the non-opioid pain regimen will provide equivalent relief as compared to the opioid regimen.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Multi-Modal Pain Protocol with and without Opioids Following Total Joint Arthroplasty
Masking: Double (Participant, Investigator)
Primary purpose: Treatment