Post-Operative Pain Control Following Shoulder Surgery

Johns Hopkins University

Status: Completed

Conditions: Shoulder Pain

Treatments: Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

Study type: Interventional

Funder types: Other

Identifiers

NCT04622839

IRB00248454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 3 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

Group 2

Experimental group

Description:

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.

Treatment:

Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

Group 3

Experimental group

Description:

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.

Treatment:

Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)