N/A
N=82
Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty
Shoulder Surgery
Bottom Line
View on ClinicalTrials.gov: NCT04294680 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Visual Analog Score (VAS) at Week 2 — 1.4; 1.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryotherapy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Campbell Clinic
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Score (VAS) at Week 2 |
1.4; 1.8 | — |
| SECONDARY Number of Opioid Pain Pills Taken |
4.3; 17.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04294680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.