Caffeine Study for Pain Control Following Total Joint Replacement

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Double Blinded Randomized Placebo Controlled Study of the Efficacy of Caffeine as an Analgesic Adjuvant for Acute Perioperative Pain Management Following Total Joint Arthroplasty

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Caffeine
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caffiene<br>This group will receive 150mg caffeine tablets to be taken twice per day | Drug: Caffeine<br>* caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo oral tablet<br>* oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain | 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. | 2 weeks post-operative |