Nonopioid Analgesia After Labral Surgery
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/2/2019 |
Start Date: | January 22, 2019 |
End Date: | May 20, 2020 |
Contact: | Toufic R Jildeh, MD |
Email: | tjildeh1@hfhs.org |
Phone: | 517-230-8511 |
Traditional vs. Nonopioid Analgesia After Labral Surgery
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
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
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.
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.
Eligibility Criteria:
Inclusion Criteria:
- All adult patients over age 18 and scheduled for a primary or revision labral surgery
Exclusion Criteria:
- Exclusion criteria will include patients with a medical history of known allergies or
intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin,
dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of
narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI
bleeding. Secondary exclusion criterion is an intact rotator cuff
We found this trial at
1
site
Click here to add this to my saved trials