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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: Tylenol and NSAIDS (Ibuprofen, diclofenac)

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Howard County General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons (ASES) score	standardized questionnaire for the assessment of shoulder function; single score which ranges from 0-100 with higher score reflecting higher function	2-4 months postop

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: American Shoulder and Elbow Surgeons
• Investigators: Principal Investigator: Umasuthan Srikumaran, M.D., Johns Hopkins Orthopedics

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: November 7, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain, Postoperative; Shoulder Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Diclofenac; Ibuprofen
• Other Study ID Numbers: IRB00248454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No