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NCT Number: NCT03825809

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

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location status: Recruiting

Location contact

Toufic R Jildeh, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Post-Operative Non Opioid Pain Protocol

Other names: Celebrex

Hydrocodone-Acetaminophen

Drug

Traditionally used narcotic pain protocol

Other names: Norco

Ketorolac

Drug

Post-Operative Non Opioid Pain Protocol

Other names: Toradol

Gabapentin

Drug

Post-Operative Non Opioid Pain Protocol

Other names: Neurontin

Acetaminophen

Drug

Post-Operative Non Opioid Pain Protocol

Other names: Tylenol

Diazepam

Drug

Post-Operative Non Opioid Pain Protocol

Other names: Valium

Primary outcomes

  1. Pain Levels

    Time frame: 10 days post-operatively

    Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.

  2. Patient-Reported Outcomes Measurement Information System

    Time frame: 10 days post-operatively

    Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.

Study contacts

Contact information is provided by the study sponsor or research team.

Toufic R Jildeh, MD

CONTACT

[email protected]

517-230-8511

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Traditional vs. Nonopioid Analgesia After Labral Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2019
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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