Caffeine Study for Pain Control Following Total Joint Replacement

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04280263
• Other study ID #: 2020 DP
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: August 2021

Study information

• Verified date: February 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: August 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Caffeine
caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day
• Placebo oral tablet
oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day

Locations

Country	Name	City	State
United States	Rothman Orthopaedics at Egg Harbor Township	Egg Harbor Township	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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