Status:
UNKNOWN
Pain Management After Shoulder Arthroplasty
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Caffeine
Pain, Joint
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of thi...
Eligibility Criteria
Inclusion
- Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty
- Patient willing and able to complete postoperative surveys
- Post-Menopausal Women and Men over the age of 55
Exclusion
- Patients reporting caffeine consumption in excess of 300mg daily
- Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse.
- Patient has history of cardiac diseases that might be aggravated by the use of caffeine, as diagnosed by a cardiologist or demonstrated by an abnormal EKG.
- Patient has a known allergy to aspirin or caffeine.
- Patient has history of cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain.
- Patient has history of anxiety disorder
- Patients with known sleep disturbances that would otherwise be affected by caffeine
- Patients undergoing revision surgery
- Patients who require alternate DVT prophylaxis other than ASA.
- Patients undergoing inpatient arthroplasty
- Workman's comp patient or patient has current litigation pending
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04872270
Start Date
April 15 2021
End Date
April 15 2022
Last Update
May 4 2021
Active Locations (1)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107