Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Surgery
• Intervention / Treatment: Device: Cryotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38138
      • Campbell Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opiate Sparing; 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; see opiate sparing description
No Intervention: Opiate Based; 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?

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

Collaborators and Investigators

• Sponsor: Campbell Clinic
• Investigators: Principal Investigator: Tyler Brolin, MD, Campbell Clinic

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BMH 19-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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