Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

NCT ID: NCT04294680

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-05-31

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.

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.

Conditions

Shoulder Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: DEVICE

see opiate sparing description

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cryotherapy

see opiate sparing description

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campbell Clinic

OTHER

Sponsor Role: lead

Responsible Party

Tyler J. Brolin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tyler Brolin, MD

Role: PRINCIPAL_INVESTIGATOR

Campbell Clinic

Locations

Campbell Clinic

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BMH 19-29

Identifier Type: -

Identifier Source: org_study_id