NCT04872270

Pain Management After Shoulder Arthroplasty

Multimodal Postoperative Pain Management Following Shoulder Arthroplasty

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Caffeine
• Pain, Joint

Interventions

Type	Name	Description
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
DRUG	Percocet 10Mg-325Mg Tablet	given postoperatively as standard post-op pain management
DRUG	Zofran 4Mg Tablet	given postoperatively as standard post-op management

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2021-05-04
• Last updated: 2021-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study