NCT04280263UnknownNot Applicable
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
Rothman Institute Orthopaedics1 site in 1 country70 target enrollmentStarted: February 28, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- post-operative pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Caffiene
Active Comparator
This group will receive 150mg caffeine tablets to be taken twice per day
Intervention: Caffeine (Drug)
placebo
Placebo Comparator
Intervention: Placebo oral tablet (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Recruiting
Not Applicable
A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & GrowthSkeletal Muscle Strength & GrowthNCT06127849Vedic Lifesciences Pvt. Ltd.138
Completed
Phase 1
Safety and Pharmacokinetic Trial in Healthy HIV-Negative Women to Assess the Delivery of Dapivirine From a Vaginal RingHIV InfectionsNCT02920827International Partnership for Microbicides, Inc.16
Completed
Phase 1
A Safety Study to Assess the Delivery of Dapivirine From a Matrix Vaginal RingHIV InfectionsNCT01144676International Partnership for Microbicides, Inc.45
Completed
Phase 1
A Prospective Randomized Double-Blinded Placebo Controlled, Explorative Phase I Trial to Investigate the Safety and Tolerability of Two Different Doses of Topically Administered APOSEC™ in Healthy Male Subjects With Artificial Dermal WoundsHealthyArtificial Dermal WoundNCT02284360Medical University of Vienna10
Terminated
Phase 3
Oral Epalrestat Therapy in Pediatric Subjects With PMM2-CDGPmm2-CDGPhosphomannomutase 2 DeficiencyPhosphomannomutase 2 Congenital Disorder of GlycosylationPhosphomannomutase II Congenital Disorder of GlycosylationPhosphomannomutase II DeficiencyNCT04925960Maggie's Pearl, LLC42