Post-Operative Pain Control Following Shoulder Surgery

Shoulder Pain Clinical Trial

Official title:

Post-Operative Pain Control Following Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622839
• Other study ID #: IRB00248454
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: April 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Shoulder Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Howard County General Hospital	Columbia	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	American Shoulder and Elbow Surgeons

Country where clinical trial is conducted

United States, 

Outcome

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