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Clinical Trials/NCT04622839
NCT04622839CompletedNot Applicable

Post-Operative Pain Control Following Shoulder Surgery

Johns Hopkins University2 sites in 1 country74 target enrollmentStarted: December 1, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
74
Locations
2
Primary Endpoint
Morphine milligram equivalents (MMEs) consumed

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

participants will be masked to the aspect of post-operative pain management being manipulated in this study; investigator and outcomes assessor will be masked to randomization (group assignment) of participants

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Morphine milligram equivalents (MMEs) consumed

Time Frame: 2 weeks postop

Total possible narcotic pain medication use in MME's

Office Contacts

Time Frame: 2 weeks postop

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

Opioid Prescription Refills

Time Frame: 2 weeks postop

number and quantity of opioid prescription refills

Secondary Outcomes

  • American Shoulder and Elbow Surgeons (ASES) score(2-4 months postop)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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