Pain Management After Shoulder Arthroplasty

NCT04872270 | Unknown Phase 3 FDA Drug

• 1 other identifier: FTJO21D.060
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Caffeine; Pain, Joint

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Caffeine Group

ACTIVE COMPARATOR

2 week supply of 100mg caffeine + aspirin 325mg + standard pain regimen (experimental)

Procedure: Total Shoulder Arthroplasty; Drug: Caffeine Pill; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet

No Caffeine Group

ACTIVE COMPARATOR

aspirin 325mg + standard pain (control)

Procedure: Total Shoulder Arthroplasty; Drug: Percocet 10Mg-325Mg Tablet; Drug: Zofran 4Mg Tablet

Interventions

Total Shoulder Arthroplasty PROCEDURE

Participant will have total shoulder replacement

Caffeine Group; No Caffeine Group

Caffeine Pill DRUG

2 week supply of 1000 mg caffeine given postoperatively as part of the pain regimen

Caffeine Group

Percocet 10Mg-325Mg Tablet DRUG

given postoperatively as standard post-op pain management

Caffeine Group; No Caffeine Group

Zofran 4Mg Tablet DRUG

given postoperatively as standard post-op management

Caffeine Group; No Caffeine Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Arthralgia

Interventions

Arthroplasty, Replacement, Shoulder; Caffeine; oxycodone-acetaminophen; Ondansetron; Tablets

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 4, 2021
• Study Start: April 15, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

US (1)