Pain Management After Shoulder Arthroplasty

Status unconfirmed · Phase 3

Conditions studied: Caffeine, Pain, Joint

In brief

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.

Key facts

Study ID: NCT04872270
Run by: Rothman Institute Orthopaedics
People needed: 160
Starts: 2021-04-15
Expected to finish: 2022-04-15
Last updated by the study team: 2021-05-04

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.