Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

NCT04294680 | Completed Results FDA Device

• 1 other identifier: BMH 19-29
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Opioid Pain Pills Taken

  Post-operative Day 1 through 12 weeks

Study Arms (2)

Opiate Sparing

EXPERIMENTAL

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

Opiate Based

NO INTERVENTION

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

Interventions

Cryotherapy DEVICE

see opiate sparing description

Opiate Sparing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary shoulder arthroplasty
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campbell Clinic: lead

Study Sites (1)

Campbell Clinic

Memphis, Tennessee, 38138, United States

Location

MeSH Terms

Interventions

Cryotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Principal Investigator
• Organization: Campbell Clinic

tbrolin@campbellclinic.com

9017595522

Study Officials

• Tyler Brolin, MD

  Campbell Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 4, 2020
• Study Start: August 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 6, 2022
• Results First Posted: December 6, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)