Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

Campbell Clinic

Status: Completed

Conditions: Shoulder Surgery

Treatments: Device: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04294680

BMH 19-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Opiate Sparing

Experimental group

Description:

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

Treatment:

Device: Cryotherapy

Opiate Based

No Intervention group

Description:

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