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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 : Unknown
Verified February 2020 by Rothman Institute Orthopaedics.
Recruitment status was:  Enrolling by invitation
First Posted : February 21, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE February 19, 2020
First Posted Date  ICMJE February 21, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE February 28, 2020
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caffeine Study for Pain Control Following Total Joint Replacement
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: Caffeine
    caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day
  • Drug: Placebo oral tablet
    oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day
Study Arms  ICMJE
  • Active Comparator: Caffiene
    This group will receive 150mg caffeine tablets to be taken twice per day
    Intervention: Drug: Caffeine
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo oral tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 19, 2020)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04280263
Other Study ID Numbers  ICMJE 2020 DP
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP