- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03825809
Nonopioid Analgesia After Labral Surgery
Traditional vs. Nonopioid Analgesia After Labral Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Toufic R Jildeh, MD
- Phone Number: 517-230-8511
- Email: tjildeh1@hfhs.org
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Health System
-
Contact:
- Toufic R Jildeh, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Post-Operative Non Opioid Pain Protocol
Patients will be administered a post-operative non-opioid pain protocol consisting of: Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam |
Post-Operative Non Opioid Pain Protocol
Other Names:
Post-Operative Non Opioid Pain Protocol
Other Names:
Post-Operative Non Opioid Pain Protocol
Other Names:
Post-Operative Non Opioid Pain Protocol
Other Names:
Post-Operative Non Opioid Pain Protocol
Other Names:
|
Active Comparator: Post-Operative Traditional Pain Protocol
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325
|
Traditionally used narcotic pain protocol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 days post-operatively
|
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.
|
10 days post-operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Toufic R Jildeh, MD, Henry Ford Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antipyretics
- Antiemetics
- Gastrointestinal Agents
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Respiratory System Agents
- Cyclooxygenase 2 Inhibitors
- Neuromuscular Agents
- Antitussive Agents
- Muscle Relaxants, Central
- Gabapentin
- Ketorolac
- Celecoxib
- Acetaminophen
- Diazepam
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- 1231914
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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