Narcotic Use
Conditions
Brief summary
This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen
Detailed description
Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring rotator cuff repair will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty. Patients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure. Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables.
Interventions
DRUGCelecoxib
Post-Operative Non Opioid Pain Protocol
Traditionally used narcotic pain protocol
DRUGKetorolac
Post-Operative Non Opioid Pain Protocol
DRUGGabapentin
Post-Operative Non Opioid Pain Protocol
DRUGAcetaminophen
Post-Operative Non Opioid Pain Protocol
DRUGDiazepam
Post-Operative Non Opioid Pain Protocol
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Eligibility Criteria: Inclusion Criteria: * All adult patients over age 18 and scheduled for a primary or revision labral surgery
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Levels | 10 days post-operatively | Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control. |
| Patient-Reported Outcomes Measurement Information System | 10 days post-operatively | Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference. |
Countries
United States
Contacts
Primary ContactToufic R Jildeh, MD
Outcome results
None listed