Pain Management After Shoulder Arthroplasty

Phase 3

• Conditions: Caffeine; Pain, Joint
• Interventions: Procedure: Total Shoulder Arthroplasty; Drug: Caffeine Pill; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet

• Registration Number: NCT04872270
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Primary Completion: 2022-04-15
• Study Completion: 2022-04-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caffeine Group	Total Shoulder Arthroplasty	2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
Caffeine Group	Caffeine Pill	2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
Caffeine Group	Zofran 4Mg Tablet	2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
No Caffeine Group	Total Shoulder Arthroplasty	aspirin 325mg + standard pain (control)
No Caffeine Group	Percocet 10Mg-325Mg Tablet	aspirin 325mg + standard pain (control)
No Caffeine Group	Zofran 4Mg Tablet	aspirin 325mg + standard pain (control)
Caffeine Group	Percocet 10Mg-325Mg Tablet	2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States