Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

Not Applicable

Completed

• Conditions: Shoulder Surgery
• Interventions: Device: Cryotherapy

• Registration Number: NCT04294680
• Lead Sponsor: Campbell Clinic

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.

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Results First Submitted: 2022-10-18
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Results First Posted: 2022-12-06
• Last Update Posted: 2022-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opiate Sparing	Cryotherapy	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

Primary Outcome Measures

Name	Time	Method
Visual Analog Score (VAS) at Week 2	postoperative day fourteen (two weeks)	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).

Secondary Outcome Measures

Name	Time	Method
Number of Opioid Pain Pills Taken	Post-operative Day 1 through 12 weeks	The total number of opioid pain pills consumed from post-operative day 1 to Week 12

Trial Locations

Locations (1)

Campbell Clinic; 🇺🇸 Memphis, Tennessee, United States