Status:
UNKNOWN
Caffeine Study for Pain Control Following Total Joint Replacement
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, double blinded, single center, randomized controlled study to evaluate the efficacy of caffeine in combination with acetyl salicylic acid (ASA) in the management of postoperative pain i...
Eligibility Criteria
Inclusion
- Patient is older than 18 years old at the time of the surgery.
- Patient is treated by Rothman Orthopaedics institute and is scheduled for the surgical procedure at AtlantiCare Regional Medical Center.
- Patient is undergoing total hip or total knee arthroplasty.
- Patient has the diagnosis of Osteoarthritis of the hip or the knee, or other noninflammatory disease that results in joint damage to the hip or the knee.
Exclusion
- Patient has known history of opioid addiction and/or has taken opioids preoperatively.
- 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 chronic pain that required the intervention of a pain management doctor.
- Patient has an active infection at the time of surgery (systemic or localized) or history of chronic infections that affected the lower extremities.
- Patient has history of cancer that would affect patient reported outcomes including pain.
- Patient has history of neuropathic pain or nerve degenerative disease.
- Patients undergoing revision surgery would be excluded.
- Patients who require alternate DTV prophylaxis other than ASA.
Key Trial Info
Start Date :
February 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04280263
Start Date
February 28 2020
End Date
August 1 2021
Last Update
October 19 2020
Active Locations (1)
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1
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor, New Jersey, United States, 08234