Nonopioid Analgesia After Arthroscopic Meniscus Surgery
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | January 22, 2019 |
End Date: | May 20, 2020 |
Contact: | Toufic R Jildeh, MD |
Email: | tjildeh1@hfhs.org |
Phone: | 5172308511 |
Traditional vs. Nonopioid Analgesia After Arthroscopic Meniscus 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
arthroscopic meniscus surgery: a treatment group given a non-opioid 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
arthroscopic meniscus surgery: a treatment group given a non-opioid 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 arthroscopic meniscus surgery 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 Visual Analog Score and Patient
Reported Outcome Measurement Informatics Systems. 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 arthroscopic meniscus surgery 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 Visual Analog Score and Patient
Reported Outcome Measurement Informatics Systems. 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.
Inclusion Criteria:
- All adult patients over age 18 scheduled for arthroscopic meniscus repair or partial
menisectomy
Exclusion Criteria:
- 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.
We found this trial at
1
site
Click here to add this to my saved trials