Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
NCT ID: NCT03818932
Last Updated: 2021-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
62 participants
INTERVENTIONAL
2019-01-22
2020-05-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Celecoxib
Post-Operative Non Opioid Pain Protocol
Ketorolac
Post-Operative Non Opioid Pain Protocol
Gabapentin
Post-Operative Non Opioid Pain Protocol
Acetaminophen
Post-Operative Non Opioid Pain Protocol
Diazepam
Post-Operative Non Opioid Pain Protocol
Post-Operative Traditional Pain Protocol
Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen
Hydrocodone-Acetaminophen
Traditionally used narcotic pain protocol
Interventions
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Celecoxib
Post-Operative Non Opioid Pain Protocol
Hydrocodone-Acetaminophen
Traditionally used narcotic pain protocol
Ketorolac
Post-Operative Non Opioid Pain Protocol
Gabapentin
Post-Operative Non Opioid Pain Protocol
Acetaminophen
Post-Operative Non Opioid Pain Protocol
Diazepam
Post-Operative Non Opioid Pain Protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
Yes
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Toufic R. Jildeh
Resident
Principal Investigators
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Toufic R Jildeh, MD
Role: PRINCIPAL_INVESTIGATOR
Resident
Locations
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Henry Ford Health System
Detroit, Michigan, United States
Countries
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Other Identifiers
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123192
Identifier Type: -
Identifier Source: org_study_id
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