Caffeine Study for Pain Control Following Total Joint Replacement

NCT04280263 | Unknown

• 1 other identifier: 2020 DP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Caffiene

ACTIVE COMPARATOR

This group will receive 150mg caffeine tablets to be taken twice per day

Drug: Caffeine

placebo

PLACEBO COMPARATOR

Drug: Placebo oral tablet

Interventions

Caffeine DRUG

caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day

Caffiene

Placebo oral tablet DRUG

oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedics at Egg Harbor Township

Egg Harbor, New Jersey, 08234, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: February 28, 2020
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-02

Locations

US (1)