Pain Management After Shoulder Arthroplasty

Caffeine Clinical Trial

Official title:

Multimodal Postoperative Pain Management Following Shoulder Arthroplasty

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04872270
• Other study ID #: FTJO21D.060
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: April 15, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: May 2021
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Caffeine
• Pain, Joint

Intervention

Procedure:
• Total Shoulder Arthroplasty
Participant will have total shoulder replacement

Drug:
• Caffeine Pill
2 week supply of 1000 mg caffeine given postoperatively as part of the pain regimen
• Percocet 10Mg-325Mg Tablet
given postoperatively as standard post-op pain management
• Zofran 4Mg Tablet
given postoperatively as standard post-op management

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative shoulder function	This will be measured using the Simple Shoulder Test (SST) which consist of 12 questions	24 weeks
Primary	Postoperative shoulder function	This will be measured using the American Shoulder and Elbow Surgeon Survey (ASES)	24 weeks
Primary	Postoperative Pain	This will be measured using the Visual Analog Scale for Pain (VAS) survey	15 days