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Caffeine Study for Pain Control Following Total Joint Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04280263
Recruitment Status : Enrolling by invitation
First Posted : February 21, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Caffeine Drug: Placebo oral tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Active Comparator: Caffiene
This group will receive 150mg caffeine tablets to be taken twice per day
Drug: Caffeine
caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day

Placebo Comparator: placebo Drug: Placebo oral tablet
oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day




Primary Outcome Measures :
  1. post-operative pain [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280263


Locations
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United States, New Jersey
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor Township, New Jersey, United States, 08234
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04280263    
Other Study ID Numbers: 2020 DP
First Posted: February 21, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents