Nonopioid Analgesia After Labral Surgery

Henry Ford Health

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Narcotic Use

Treatments: Drug: Ketorolac; Drug: Hydrocodone-Acetaminophen; Drug: Acetaminophen; Drug: Diazepam; Drug: Gabapentin; Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT03825809

1231914

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Post-Operative Non Opioid Pain Protocol

Experimental group

Description:

Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam

Treatment:

Drug: Celecoxib

Drug: Gabapentin

Drug: Diazepam

Drug: Acetaminophen

Drug: Ketorolac

Post-Operative Traditional Pain Protocol

Active Comparator group

Description:

Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325

Treatment:

Drug: Hydrocodone-Acetaminophen