Caffeine Study for Pain Control Following Total Joint Replacement

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Drug: Caffeine; Drug: Placebo oral tablet

• Registration Number: NCT04280263
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Study Start: 2020-02-28
• Last Update Submitted: 2020-10-16
• Last Update Posted: 2020-10-19
• Primary Completion: 2021-06
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffiene	Caffeine	This group will receive 150mg caffeine tablets to be taken twice per day
placebo	Placebo oral tablet	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rothman Orthopaedics at Egg Harbor Township; 🇺🇸 Egg Harbor Township, New Jersey, United States