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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03422211
Other study ID # 28494
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2017
Est. completion date November 2, 2018

Study information

Verified date September 2021
Source St. Louis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 223
Est. completion date November 2, 2018
Est. primary completion date November 2, 2018
Accepts healthy volunteers
Gender All
Age group 10 Years to 100 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States Anheuser Busch Institute Saint Louis Missouri
United States Cardinal Glennon Saint Louis Missouri
United States SSM Health St. Mary's Hospital - St. Louis Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

References & 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 Determin — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of narcotic analgesics consumed Quantify narcotic analgesics 2 months
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