Pain Management After Shoulder Arthroplasty

Multimodal Postoperative Pain Management Following Shoulder Arthroplasty

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Caffeine; Pain, Joint
• Intervention / Treatment: Procedure: Total Shoulder Arthroplasty; Drug: Caffeine Pill; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caffeine Group; 2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)	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
Active Comparator: No Caffeine Group; aspirin 325mg + standard pain (control)	Procedure: Total Shoulder Arthroplasty; Participant will have total shoulder replacement; Drug: Percocet 10Mg-325Mg Tablet; given postoperatively as standard post-op pain management; Drug: Zofran 4Mg Tablet; given postoperatively as standard post-op management

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): April 15, 2022
• Study Completion (Anticipated): April 15, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: FTJO21D.060

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes