Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction

Study Design: This is a randomized, single blinded, standard of care-controlled clinical
trial. All adult patients over eighteen desiring anterior cruciate ligament reconstruction
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 Analogue Scale and
Patient-Reported Outcomes Measurement Information System. 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 anterior
cruciate ligament reconstruction

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 anterior cruciate ligament
reconstruction