Clinical trial NCT04872270: Pain Management After Shoulder Arthroplasty
Official title: Multimodal Postoperative Pain Management Following Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Caffeine
Pain, Joint
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 160
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain control is a critical after many surgical procedures. It is well known that orthopaedic surgeries are among the most painful procedures, with total joint arthroplasty being a clear example of this situation. Current trends in pain management are morphing and multimodal opioid sparing protocols are now being evaluated and implemented, with results showing a decrease in the amount of opioids being prescribed. Despite all efforts, most patients experience pain and, in order to control it, multiple medications have been tried with variable results. The most commonly prescribed medications are opioids, but side effects associated with their use as well as their addictive potential are making them a less desirable option for patients. Currently there is a trend towards diminishing opioids consumption and prescribing alternative pain control regimens.Caffeine is a well known molecule that when associated with non-steroidal anti-inflammatory drugs (NSAIDS) potentiates their analgesic effect and decreases the amount of doses required to control pain. Little is known about the effect of caffeine over pain relief in patients undergoing total joint arthroplasty, but preliminary results in other fields make us believe it could have a potential benefit for patients undergoing total joint arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Adult patients who undergo primary Total Shoulder Arthroplasty or Reverse Total Shoulder Arthroplasty
* Patient willing and able to complete postoperative surveys
* Post-Menopausal Women and Men over the age of 55

Exclusion Criteria:

* Patients reporting caffeine consumption in excess of 300mg daily
* Patient has known history of opioid addiction, has taken opioids preoperatively, or other forms of substance abuse.
* 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 cancer, neuropathic pain, or nerve degenerative disease that would affect patient reported outcomes including pain.
* Patient has history of anxiety disorder
* Patients with known sleep disturbances that would otherwise be affected by caffeine
* Patients undergoing revision surgery
* Patients who require alternate DVT prophylaxis other than ASA.
* Patients undergoing inpatient arthroplasty
* Workman's comp patient or patient has current litigation pending

Primary outcomes:
measure: postoperative shoulder function
timeFrame: 24 weeks
measure: Postoperative shoulder function
timeFrame: 24 weeks
measure: Postoperative Pain
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: