Caffeine Study for Pain Control Following Total Joint Replacement

Rothman Institute Orthopaedics

Status

Unknown

Conditions

Pain, Postoperative

Treatments

Drug: Placebo oral tablet

Drug: Caffeine

Study type

Interventional

Funder types

Other

Identifiers

NCT04280263

2020 DP

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.