Back to resultsCaffeine Study for Pain Control Following Total Joint Replacement
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caffeine
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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.
Sites / Locations
- Rothman Orthopaedics at Egg Harbor Township
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Caffiene
placebo
Arm Description
This group will receive 150mg caffeine tablets to be taken twice per day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04280263
First Posted
February 19, 2020
Last Updated
October 16, 2020
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04280263
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Caffiene
Arm Type
Active Comparator
Arm Description
This group will receive 150mg caffeine tablets to be taken twice per day
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day
Primary Outcome Measure Information:
Title
post-operative pain
Description
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.
Time Frame
2 weeks post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Rothman Orthopaedics at Egg Harbor Township
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Caffeine Study for Pain Control Following Total Joint Replacement
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