ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,180 studies in Pain, Postoperative with a site in United States — 203 open to participants now, 236 under way, 25 of them phase 3. Pain, Postoperative · United States.

Enrollment
29th of 82
223 · median 130
Started
2017
with 77 others
Observational
82 of 1,180
18 open now
Registered
512th of 1,180
by date

Among the 1,180 studies in Pain, Postoperative with a site in United States, this one is the 29th largest by enrollment of the 82 observational ones that give a count, is one of 78 that started in 2017, is one of 82 observational ones, and was the 512th registered.

Pain, Postoperative

5,648 studies on the registry are indexed under Pain, Postoperative; 1,231 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

203 of the 1,180 studies in Pain, Postoperative with a site in United States are open now. Recruiting first, the newest first:

198 more — sign in →

All 203 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 240 (35%) set no upper age limit and 329 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 10 Years to 100 Years · all sexes.

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02

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)

03

Conditions studied

  • Narcotic Use
  • Postoperative Pain
  • Narcotic Abuse
  • Opioid Use
  • Opioid Abuse, Uncomplicated
  • Opioids; Harmful Use
  • Analgesic Drug Dependence
  • Orthopedic Disorder
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

05

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.

06

What researchers measure

Primary outcomes

  1. Number of narcotic analgesics consumed

    Quantify narcotic analgesics

    Time frame: 2 months

07

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
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2017 to primary completion in Nov 2018, 11 months.

Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 11 months is close to that.

Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 30, 2018
First posted
Feb 5, 2018
StartActual
Nov 16, 2017
Primary completionActual
Nov 2, 2018
CompletionActual
Nov 2, 2018
Last update
Sep 24, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03422211
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 ↗

Not currently enrolling

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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