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Nonopioid Analgesia After Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT03818919
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Toufic R. Jildeh, Henry Ford Health System

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Drug: Celecoxib Drug: Ketorolac Drug: Gabapentin Drug: Acetaminophen Drug: Diazepam Drug: Hydrocodone-Acetaminophen Phase 2

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : May 20, 2020

Arm Intervention/treatment
Experimental: Post-Operative Non Opioid Pain Protocol
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Drug: Celecoxib
Post-Operative Non Opioid Pain Protocol
Other Name: Celebrex

Drug: Ketorolac
Post-Operative Non Opioid Pain Protocol
Other Name: Tylenol

Drug: Gabapentin
Post-Operative Non Opioid Pain Protocol
Other Name: Neurontin

Drug: Acetaminophen
Post-Operative Non Opioid Pain Protocol
Other Name: Tylenol

Drug: Diazepam
Post-Operative Non Opioid Pain Protocol
Other Name: Valium

Active Comparator: Post-Operative Traditional Pain Protocol
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Drug: Hydrocodone-Acetaminophen
Traditionally used narcotic pain protocol
Other Name: Norco




Primary Outcome Measures :
  1. Pain Levels [ Time Frame: 10 days post-operatively ]
    Patients record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. 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) once every night for 10 days post-operatively. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818919


Contacts
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Contact: Toufic R Jildeh, MD 5172308511 tjildeh1@hfhs.org

Locations
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United States, Michigan
Health Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Toufic R Jildeh, MD         
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Toufic R Jildeh, MD Resident

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Responsible Party: Toufic R. Jildeh, Resident, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03818919     History of Changes
Other Study ID Numbers: 123191
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Per Request

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Acetaminophen
Celecoxib
Ketorolac
Ketorolac Tromethamine
Acetaminophen, hydrocodone drug combination
Diazepam
Analgesics, Non-Narcotic
Gabapentin
Hydrocodone
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants