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

Rothman Institute Orthopaedics1 site in 1 country70 target enrollmentFebruary 28, 2020

ConditionsPain, Postoperative

InterventionsCaffeine Placebo oral tablet

Overview

Phase: N/A
Intervention: Caffeine
Conditions: Pain, Postoperative
Sponsor: Rothman Institute Orthopaedics
Enrollment: 70
Locations: 1
Primary Endpoint: post-operative pain
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 28, 2020

End Date

August 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rothman Institute Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

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.