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Completed

NCT Number: NCT04622839

Post-Operative Pain Control Following Shoulder Surgery

This study will evaluate overall opioid and non-narcotic analgesic use following surgical treatment for shoulder pathology, and recommend evidence based guidelines for standardized postoperative pain management.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Howard County General Hospital

Columbia, Maryland, 21045, United States

About this study

There is currently very limited information in the literature regarding postoperative pain medication consumption following orthopedic shoulder surgery. To fill this knowledge gap, this study will evaluate overall opioid consumption in morphine milligram equivalents following surgical treatment for shoulder pathology.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Opioid-naive adults age 18-90 years old planning to undergo surgical treatment for shoulder pathology with the PI at Johns Hopkins Shoulder Service (Columbia, Odenton clinic sites; Howard County General Hospital/Johns Hopkins Hospital operative sites) will be included.

Exclusion criteria

  • Patients with prior history of opioid misuse, addiction, or chronic pain
  • Patients taking chronic pain medication or have taken opioid medication in the past 3 months will be excluded due to risk of developing drug tolerances that could affect the amount of pain medication consumed after surgery An exception will be made for those who have used narcotic medication for fracture-related events, and expect to undergo surgical treatment for fracture repair (ORIF or arthroplasty)
  • Patients with BMI < 18.5 or > 39.9
  • Patients with a history of adverse reaction and/or allergy to oxycodone
  • Patients lacking the ability to consent will also be excluded.
  • Patients whose primary residence is outside the United States will be excluded.
  • Patients who are unable to complete questionnaires due to medical condition, psychiatric illness, or significant language barrier will also be excluded.

Treatment and study plan

Tylenol and NSAIDS (Ibuprofen, diclofenac)

Other

This study will assess an aspect of perioperative care relating to pain control. Subjects will not be aware of which aspect is randomized, but will be given a list of possible aspects which will include the intervention (listed below):

  • Agents used in nerve block (lidocaine vs ropivacaine)
  • Location of injection for analgesic
  • Use of over-the-counter pain management (including but not limited to acetaminophen, ibuprofen, naproxen, etc.)
  • Type of initial opioid prescribed (including but not limited to oxycodone, tramadol, hydrocodone, etc.)
  • Number of pills in the initial opioid prescription
  • Instructions for sling wear (duration of use or type of sling)
  • Ice usage (duration of use and frequency of use)

Blinding the participant to the randomized aspect of this study will help prevent bias in patient responses for outcome scores and medication usage.

Primary outcomes

  1. Morphine milligram equivalents (MMEs) consumed

    Time frame: 2 weeks postop

    Total possible narcotic pain medication use in MME's

  2. Opioid Prescription Refills

    Time frame: 2 weeks postop

    number and quantity of opioid prescription refills

  3. Office Contacts

    Time frame: 2 weeks postop

    Number of times patient contacted the office via telephone, MyChart, or email

Secondary outcomes

  1. American Shoulder and Elbow Surgeons (ASES) score

    Time frame: 2-4 months postop

    standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American Shoulder and Elbow Surgeons

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 10, 2020
Registry last updated
Feb 16, 2023

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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