Pain, Postoperative
Conditions
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 in patients undergoing total joint arthroplasty.
Interventions
DRUGCaffeine
caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day
DRUGPlacebo oral tablet
oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-operative pain | 2 weeks post-operative | pain will be recorded via Visual Analog Scale (VAS). The scale ranges from zero to 100 with zero being no pain and 100 being worst pain imaginable. |
Countries
United States
Outcome results
None listed