Nonopioid Analgesia After Rotator Cuff Repair
Primary Purpose
Rotator Cuff Tear
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Ketorolac
Gabapentin
Acetaminophen
Diazepam
Hydrocodone-Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear
Eligibility 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
Sites / Locations
- Health Ford Health SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Post-Operative Non Opioid Pain Protocol
Post-Operative Traditional Pain Protocol
Arm Description
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Outcomes
Primary Outcome Measures
Pain Levels
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.
Patient-Reported Outcomes Measurement Information System
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03818919
First Posted
January 22, 2019
Last Updated
January 24, 2019
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03818919
Brief Title
Nonopioid Analgesia After Rotator Cuff Repair
Official Title
Traditional vs. Nonopioid Analgesia After Rotator Cuff Repair
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
January 20, 2020 (Anticipated)
Study Completion Date
May 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Post-Operative Non Opioid Pain Protocol
Arm Type
Experimental
Arm Description
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam
Arm Title
Post-Operative Traditional Pain Protocol
Arm Type
Active Comparator
Arm Description
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Post-Operative Non Opioid Pain Protocol
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Tylenol
Intervention Description
Post-Operative Non Opioid Pain Protocol
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
Post-Operative Non Opioid Pain Protocol
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Post-Operative Non Opioid Pain Protocol
Intervention Type
Drug
Intervention Name(s)
Diazepam
Other Intervention Name(s)
Valium
Intervention Description
Post-Operative Non Opioid Pain Protocol
Intervention Type
Drug
Intervention Name(s)
Hydrocodone-Acetaminophen
Other Intervention Name(s)
Norco
Intervention Description
Traditionally used narcotic pain protocol
Primary Outcome Measure Information:
Title
Pain Levels
Description
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.
Time Frame
10 days post-operatively
Title
Patient-Reported Outcomes Measurement Information System
Description
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.
Time Frame
10 days post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toufic R Jildeh, MD
Phone
5172308511
Email
tjildeh1@hfhs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toufic R Jildeh, MD
Organizational Affiliation
Resident
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toufic R Jildeh, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Per Request
Learn more about this trial
Nonopioid Analgesia After Rotator Cuff Repair
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