Acetaminophen Randomized Controlled Trial

Study Overview
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Brief Summary
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Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be given a similarly looking placebo pill. A multitude of post-op variables will be included, mainly pain scores and morphine equivalent doses at different time points.

Official Title
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Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Acetaminophen
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 years of age ASA Class I-II Patients scheduled for meniscectomy Exclusion Criteria: Contraindication to acetaminophen (hypersensitivity, extensive alcohol history, liver disease, actively breastfeeding) Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.) Younger than 18 years of age or older than 65 Any patient considered a vulnerable subject Patients on pain medication prior to surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1000 Mg Acetaminophen<br>Acetaminophen will be given 24 hours before surgery | Drug: Acetaminophen<br>* Acetaminophen will be given 24 hours before scheduled surgery.<br>|
| Active Comparator: Placebo<br>A sugar pill will be given 24 hours before the scheduled surgery. | Other: Placebo<br>* Placebo will be given to subjects 24 hours before scheduled surgery.<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine-equivalent dose consumption | Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days | 7 days | 
| Pain using the visual analogue scale | The visual analogue scale is a scale with a line from 0 on one side and 100 on the other where the patient is asked to mark where they believe their pain is. | 7 Days | 
| Narcotic Use | Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days will also be recorded. | 7 Days | 
| Measure of time to discharge from the PACU | Time to discharge from the PACU | 7 Days | 
| Measure of time to discharge from hospital | Time to discharge from the hospital | 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Surgery, Meniscectomy