Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

Study Overview
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Brief Summary
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To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and oral morphine equivalents.

Detailed Description
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This is a single center, investigator initiated, prospective, randomized, controlled trial conducted among patients who have given voluntary consent to participate. Participation will last until the completion of the twelve weeks standard of care follow up visit.

Official Title
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Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate-Based Protocol Following Shoulder Arthroplasty

Conditions
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Shoulder Surgery

Intervention / Treatment
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* Device: Cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary shoulder arthroplasty 18-85 years of age Body Mass Index greater than or equal to 45 Willing and able to provide written informed consent Willing and able to cooperative in the required postoperative therapy Willing and able to complete scheduled follow-up evaluations Fluent in verbal and written English Exclusion Criteria: Less than 18 years or over 85 years of age Unable to provide written informed consent, cooperate with postoperative therapy, or complete follow-up evaluations Known sensitivity, allergy, or intolerance to medications with protocols Renal disease as defined by active or impending dialysis within six months or kidney transplant Concomitant ipsilateral upper extremity injury or condition other than shoulder that compromises function Chronic pain syndrome Five consecutive days of opiate use with the previous ninety days Worker's compensation claim Women who are pregnant, planning to become to become pregnant, or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opiate Sparing<br>Cryotherapy one hour daily four times per day for two weeks postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeproazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative Oxycodone 5 milligrams every six hours by mouth as needed for uncontrolled pain for fourteen days postoperative | Device: Cryotherapy<br>* see opiate sparing description<br>|
| No Intervention: Opiate Based<br>Oxycodone 5 to 10 milligrams every four to six hours by mouth as needed for pain for fourteen days postoperative Acetaminophen 1000 milligrams every six hours by mouth for fourteen days postoperative Gabapentin 100 milligrams three times per day by mouth for thirty days postoperative Celecoxib 100 milligrams two times per day by mouth for thirty days postoperative Esomeprazole 20 milligrams daily by mouth for thirty days postoperative Ondansetron 4 milligrams every eight hours by mouth as needed for nausea and/or vomiting for fourteen days postoperative | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score (VAS) at Week 2 | The Visual Analog Score (VAS) is a a validated patient reported pain score with possible range from zero (no pain) to ten (worst possible pain). | postoperative day fourteen (two weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Opioid Pain Pills Taken | The total number of opioid pain pills consumed from post-operative day 1 to Week 12 | Post-operative Day 1 through 12 weeks |