Pain Management After Shoulder Arthroplasty

Overview

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.

Full Title of Study: “Multimodal Postoperative Pain Management Following Shoulder Arthroplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 15, 2022

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

Arms, Groups and Cohorts

  • Active Comparator: Caffeine Group
    • 2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)
  • Active Comparator: No Caffeine Group
    • aspirin 325mg + standard pain (control)

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rothman Institute Orthopaedics
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.