Pain Management After Shoulder Arthroplasty

• ClinicalTrials.gov Identifier: NCT04872270
• Recruitment Status: Enrolling by invitation
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Sponsor: Rothman Institute Orthopaedics
• Information provided by (Responsible Party): Rothman Institute Orthopaedics

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Caffeine; Pain, Joint	Procedure: Total Shoulder Arthroplasty; Drug: Caffeine Pill; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multimodal Postoperative Pain Management Following Shoulder Arthroplasty
• Actual Study Start Date: April 15, 2021
• Estimated Primary Completion Date: April 15, 2022
• Estimated Study Completion Date: April 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

More Information

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT04872270
• Other Study ID Numbers: FTJO21D.060
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Last Verified: May 2021

• 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

Additional relevant MeSH terms:

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Caffeine; Central Nervous System Stimulants; Physiological Effects of Drugs; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents