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History of Changes for Study: NCT04280263
Caffeine Study for Pain Control Following Total Joint Replacement
Latest version (submitted October 16, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 19, 2020 None (earliest Version on record)
2 October 16, 2020 Recruitment Status and Study Status
Comparison Format:

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Study NCT04280263
Submitted Date:  February 19, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2020 DP
Brief Title: Caffeine Study for Pain Control Following Total Joint Replacement
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
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2020
Overall Status: Enrolling by invitation
Study Start: February 2020
Primary Completion: June 2021 [Anticipated]
Study Completion: August 2021 [Anticipated]
First Submitted: February 19, 2020
First Submitted that
Met QC Criteria:
February 19, 2020
First Posted: February 21, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
February 19, 2020
Last Update Posted: February 21, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Rothman Institute Orthopaedics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Pain, Postoperative
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Outcomes Assessor)
Allocation: Randomized
Enrollment: 70 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Locations: United States, New Jersey
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor Township, New Jersey, United States, 08234
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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