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

Part of paid clinical trials in Camden, New Jersey.

Sponsor
The Cooper Health System
Study ID
NCT06133933
Status
Enrolling By Invitation

Conditions

  • Opioid Use
  • Postoperative Pain
  • Total Shoulder Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pain Threshold using algometer/dolorimeter — DEVICE
    These patients who consent to participation in the study will receive a preoperative pain threshold measured using a pain algometer/dolorimeter. We will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcomes.

Study Details

The purpose of this prospective research study is to evaluate the effects of preoperative pain threshold using a pressure algometer and its effects on postoperative patient satisfaction, return to work, and opioid consumption following Total Shoulder Arthroplasty (TSA). Participants will have their pain threshold measured at the preoperative visit. Postoperatively, they will be followed for 3 months and complete a pain journal for 2 weeks, record their medications consumed, and complete surveys at 2 weeks, 6 weeks, and 3 months. The study team will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcome.

Key Dates

Start date
May 21, 2021
Status verified
Aug 2024
Primary completion
May 21, 2026
Completion
May 21, 2027

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Study Cohort
    Patients will have their preoperative pain threshold measured and complete postoperative pain journal, pill count, VAS, SF-12, SANE, and Satisfaction Survey in addition to the routine standard of care following perioperative management of total shoulder arthroplasty patients.

Primary Outcome Measure

Postoperative opioid consumption [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University HospitalCamdenNew Jersey08103-

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