MedTrace Logo

Pain Management After Shoulder Arthroplasty

NCT04872270 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-05-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-04-15
Completion
2022-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872270 on ClinicalTrials.gov