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Search / Trial NCT06133933

Total Shoulder Arthroplasty Preoperative Pain Threshold and Association With Postoperative Opioid Consumption

Launched by THE COOPER HEALTH SYSTEM · Nov 14, 2023

Trial Information

Current as of November 12, 2025

Enrolling by invitation

Keywords

Total Shoulder Arthroplasty Postoperative Pain Postoperative Satisfaction Opioid Consumption

ClinConnect Summary

This study is watching adults who are about to have a total shoulder replacement to see if a preoperative pressure-based test of pain sensitivity (pain threshold) can predict three things after surgery: how much opioid medication they end up using in the first 3 months, how satisfied they are with their pain control, and how soon they return to work. It’s an observational study with one group of participants, not a trial with different treatments.

If you’re 18 or older and scheduled for a total shoulder replacement, you may be eligible (up to about 150 people). You’ll have your pain threshold measured before surgery using a device that applies pressure until you feel pain. After surgery, you’ll keep a simple diary of your pain medicine for two weeks and complete surveys at 2 weeks, 6 weeks, and 3 months. Your opioid use may be checked against prescription records with your permission. All data are kept securely. The study is led by Dr. Catherine Fedorka at Cooper University Hospital in Camden, NJ, and recruitment started in 2021 with completion planned around 2027.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients 18 years or older
  • Patients who are scheduled to undergo a Total Shoulder Arthroplasty
  • Exclusion Criteria:
  • Patients younger than 18 years
  • Patients who are scheduled to undergo a Total Shoulder Arthroplasty

About The Cooper Health System

The Cooper Health System is a leading academic healthcare organization dedicated to delivering high-quality clinical care, advancing medical research, and providing education in the health sciences. With a robust network of hospitals, outpatient facilities, and specialized care centers, Cooper is committed to improving patient outcomes through innovative treatments and cutting-edge clinical trials. The system's research initiatives focus on a wide range of medical disciplines, fostering collaboration among healthcare professionals and academic institutions to enhance evidence-based practices and contribute to the advancement of medical knowledge.

Locations

Camden, New Jersey, United States

Patients applied

0 patients applied

Trial Officials

Catherine J Fedorka, MD

Principal Investigator

Cooper University Hospital Department of Orthopedics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported