Post-Operative Pain Control Following Shoulder Surgery

NCT ID: NCT04622839

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-07-31

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1

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 Type: EXPERIMENTAL

Tylenol and NSAIDS (Ibuprofen, diclofenac)

Intervention Type: 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.

Group 2

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 Type: EXPERIMENTAL

Tylenol and NSAIDS (Ibuprofen, diclofenac)

Intervention Type: 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.

Group 3

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 Type: EXPERIMENTAL

Tylenol and NSAIDS (Ibuprofen, diclofenac)

Intervention Type: 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.

Interventions

Tylenol and NSAIDS (Ibuprofen, diclofenac)

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Shoulder and Elbow Surgeons

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Umasuthan Srikumaran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Orthopedics

Locations

Howard County General Hospital

Columbia, Maryland, United States

Countries

United States

Other Identifiers

IRB00248454

Identifier Type: -

Identifier Source: org_study_id