A Prospective Assessment of Opioid Utilization Post-operatively in Sports Orthopaedic Surgeries (Opioids)

September 22, 2021 updated by: John Capelle, MD, St. Louis University
There was a study titled "A prospective evaluation of opioid utilization after upper extremity surgical procedures: Identifying consumption patterns and determining prescribing guidelines" by Dr. Matzon and team from Thomas Jefferson University that came up with a simple set of opioid guidelines post-surgically. These guidelines are helping to guide surgeon's prescribing patterns and ideally limit the number of prescribed pain medicines. We plan to identify typical narcotic analgesic usage post sports orthopaedic surgery. We hope to identify the number of narcotic pain pills to prescribe to patients undergoing orthopaedic sports surgery in the future.

Study Overview

Detailed Description

1, Consent patients undergoing sports orthopaedic surgery in clinic or in pre-operative holding area and also administer first questionnaire, opioid risk tool, and pain catastrophizing scale(research) 2. Sports orthopaedic surgery (standard of care) 3. Post-op pain control regimen (standard of care) 4. Call or email patient with questionnaire every day for a week followed by weekly for 7 more weeks. The children's questionnaire will be child specific and the parent will assist the child. Will also use a picture of Wong-Baker Faces to help children identify where their pain scale is which will be given to the patient the same day that the consent is obtained to use at home(research). Questionnaire should take less than 5 minutes and will include questions about how well their pain is controlled, how many analgesic medications they have taken, and if they have tried anything else for pain. (Research) 5. Patient will continue to go to post-operative appointments as scheduled. (standard of care) 6. Will store the data from the phone calls on the secured T drive. (Research)

Study Type

Observational

Enrollment (Actual)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Cardinal Glennon
      • Saint Louis, Missouri, United States, 63110
        • Anheuser Busch Institute
      • Saint Louis, Missouri, United States, 63117
        • SSM Health St. Mary's Hospital - St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 100 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Have undergone an orthopaedic sports surgery

Description

Inclusion Criteria:

  • analgesics prescribed to patient

Patients that have undergone orthopaedic sports surgeries that Dr. Kaar and Dr. Kim performed with some of the examples being:

Acromioplasty Rotator cuff repair Labral repair Proximal humerus repair versus arthroplasty Elbow instability repair Elbow arthroplasty Hip arthroscopy Hip cam lesion repair Knee arthroscopy Knee ligament repair Knee meniscus repair Achilles tendon repair Cartilage preserving procedures

Exclusion Criteria:

mental retardation inmates non-english speaking pregnant on-call trauma cases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sports orthopaedic surgery
Patients that recently underwent orthopaedic sports surgery performed by two separate surgeons
Will ask patients questions in regards to how many narcotics they have taken and what their pain level has been.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of narcotic analgesics consumed
Time Frame: 2 months
Quantify narcotic analgesics
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: John M Capelle, MD, St. Louis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2017

Primary Completion (ACTUAL)

November 2, 2018

Study Completion (ACTUAL)

November 2, 2018

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (ACTUAL)

February 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not planning on sharing participant data in order to protect patient's confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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