Prospective, Randomized, Controlled Trial of an Opiate Sparing Protocol Versus Standard Opiate-Based Protocol Following Shoulder Arthroplasty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Shoulder Surgery
- Sponsor
- Campbell Clinic
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Visual Analog Score (VAS) at Week 2
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Tyler J. Brolin
Principal Investigator
Campbell Clinic
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
Outcomes
Primary Outcomes
Visual Analog Score (VAS) at Week 2
Time Frame: 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 Outcomes
- Number of Opioid Pain Pills Taken(Post-operative Day 1 through 12 weeks)