NCT03422211

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

January 30, 2018

Last Update Submit

September 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of narcotic analgesics consumed

    Quantify narcotic analgesics

    2 months

Study Arms (1)

Sports orthopaedic surgery

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

Other: Questionnaire

Interventions

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

Sports orthopaedic surgery

Eligibility Criteria

Age10 Years - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Have undergone an orthopaedic sports surgery

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cardinal Glennon

St Louis, Missouri, 63104, United States

Location

Anheuser Busch Institute

St Louis, Missouri, 63110, United States

Location

SSM Health St. Mary's Hospital - St. Louis

St Louis, Missouri, 63117, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain, PostoperativeNarcotic-Related DisordersOpioid-Related DisordersMusculoskeletal Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • John M Capelle, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor - Researcher

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 5, 2018

Study Start

November 16, 2017

Primary Completion

November 2, 2018

Study Completion

November 2, 2018

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

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

Locations