Post-Operative Pain Control Following Shoulder Surgery

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

• Registration Number: NCT04622839
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-11-07
• Study First Posted: 2020-11-10
• Study Start: 2020-12-01
• Status Verified: 2022-04
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Tylenol and NSAIDS (Ibuprofen, diclofenac)	Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc.
Group 2	Tylenol and NSAIDS (Ibuprofen, diclofenac)	Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc.
Group 3	Tylenol and NSAIDS (Ibuprofen, diclofenac)	Participants will not be aware of the relation to the group they are randomized into in comparison to the other study groups; for example, if they were assigned a higher or lower frequency of ice usage (with Intervention 1 being frequency of ice usage), etc.

Primary Outcome Measures

Name	Time	Method
Morphine milligram equivalents (MMEs) consumed	2 weeks postop	Total possible narcotic pain medication use in MME's
Office Contacts	2 weeks postop	Number of times patient contacted the office via telephone, MyChart, or email
Opioid Prescription Refills	2 weeks postop	number and quantity of opioid prescription refills

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons (ASES) score	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

Trial Locations

Locations (1)

Howard County General Hospital; 🇺🇸 Columbia, Maryland, United States