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Recruiting NCT03825809

Nonopioid Analgesia After Labral Surgery

Phase II / Phase III Interventional Narcotic Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Celecoxib, Hydrocodone-Acetaminophen, Ketorolac, Gabapentin.
Who it may be relevant to
Registry conditions: Narcotic Use. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Traditional vs. Nonopioid Analgesia After Labral Surgery

Overview

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

  • Drug Celecoxib
    Post-Operative Non Opioid Pain Protocol
  • Drug Hydrocodone-Acetaminophen
    Traditionally used narcotic pain protocol
  • Drug Ketorolac
    Post-Operative Non Opioid Pain Protocol
  • Drug Gabapentin
    Post-Operative Non Opioid Pain Protocol
  • Drug Acetaminophen
    Post-Operative Non Opioid Pain Protocol
  • Drug Diazepam
    Post-Operative Non Opioid Pain Protocol

Primary outcome measures

  • Pain Levels [Time frame: 10 days post-operatively]
  • Patient-Reported Outcomes Measurement Information System [Time frame: 10 days post-operatively]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Henry Ford Health System — Detroit

Identifiers

NCT: NCT03825809 · 1231914

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗