Status:
COMPLETED
Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty
Lead Sponsor:
Campbell Clinic
Conditions:
Shoulder Surgery
Eligibility:
All Genders
18-85 years
Phase:
NA
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 regardin...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04294680
Start Date
August 1 2019
End Date
May 31 2021
Last Update
December 6 2022
Active Locations (1)
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1
Campbell Clinic
Memphis, Tennessee, United States, 38138