Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty

Shoulder Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294680
• Other study ID #: BMH 19-29
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2022
• Source: Campbell Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Surgery

Intervention

Device:
• Cryotherapy
see opiate sparing description

Locations

Country	Name	City	State
United States	Campbell Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Campbell Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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