Pain Management After Shoulder Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2022-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Caffeine Pain, Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caffeine Group

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

Group Type ACTIVE_COMPARATOR

Total Shoulder Arthroplasty

Intervention Type PROCEDURE

Participant will have total shoulder replacement

Caffeine Pill

Intervention Type DRUG

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

Percocet 10Mg-325Mg Tablet

Intervention Type DRUG

given postoperatively as standard post-op pain management

Zofran 4Mg Tablet

Intervention Type DRUG

given postoperatively as standard post-op management

No Caffeine Group

aspirin 325mg + standard pain (control)

Group Type ACTIVE_COMPARATOR

Total Shoulder Arthroplasty

Intervention Type PROCEDURE

Participant will have total shoulder replacement

Percocet 10Mg-325Mg Tablet

Intervention Type DRUG

given postoperatively as standard post-op pain management

Zofran 4Mg Tablet

Intervention Type DRUG

given postoperatively as standard post-op management

Interventions

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Total Shoulder Arthroplasty

Participant will have total shoulder replacement

Intervention Type PROCEDURE

Caffeine Pill

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

Intervention Type DRUG

Percocet 10Mg-325Mg Tablet

given postoperatively as standard post-op pain management

Intervention Type DRUG

Zofran 4Mg Tablet

given postoperatively as standard post-op management

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes