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CompletedNCT03422211OpioidsUpdated Sep 24, 2021

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

An observational study in Narcotic Use, Postoperative Pain and Narcotic Abuse, sponsored by St. Louis University. Completed at 3 sites in United States. Open to participants aged 10 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-09-24.

Sponsored by St. Louis University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
223
Ages
10 Years to 100 Years
Sex
All
01

Study summary

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.

Read the 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)

02

Conditions studied

  • Narcotic Use
  • Postoperative Pain
  • Narcotic Abuse
  • Opioid Use
  • Opioid Abuse, Uncomplicated
  • Opioids; Harmful Use
  • Analgesic Drug Dependence
  • Orthopedic Disorder
03

Who can participate

Ages eligible
10 Years to 100 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Have undergone an orthopaedic sports surgery

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

Exclusion Criteria:

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

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
223 participants (actual)
Patient registry
No

Groups and cohorts

  • Sports orthopaedic surgery

    Patients that recently underwent orthopaedic sports surgery performed by two separate surgeons

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    Will ask patients questions in regards to how many narcotics they have taken and what their pain level has been.

05

What researchers measure

Primary outcomes

  1. Number of narcotic analgesics consumed

    Quantify narcotic analgesics

    Time frame: 2 months

06

Study locations

3 sites
  • Cardinal Glennon
    Saint Louis, Missouri 63104, United States
  • Anheuser Busch Institute
    Saint Louis, Missouri 63110, United States
  • SSM Health St. Mary's Hospital - St. Louis
    Saint Louis, Missouri 63117, United States
07

References and documents

Publications

  • Kim N, Matzon JL, Abboudi J, Jones C, Kirkpatrick W, Leinberry CF, Liss FE, Lutsky KF, Wang ML, Maltenfort M, Ilyas AM. A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing Guidelines. J Bone Joint Surg Am. 2016 Oct 19;98(20):e89. doi: 10.2106/JBJS.15.00614. PubMed 27869630 ↗

Individual participant data

Plan to share: No — Not planning on sharing participant data in order to protect patient's confidentiality.

08

Registry details

Key details

Study ID
NCT03422211
Lead sponsor
St. Louis University
Responsible party
John Capelle, MD (Medical Doctor - Researcher, St. Louis University) — Principal investigator
First posted
Feb 5, 2018
Start date
Nov 16, 2017
Primary completion
Nov 2, 2018
Completion
Nov 2, 2018
Last update
Sep 24, 2021

Study contacts

John M Capelle, MD
principal investigator · St. Louis University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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