Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients
Overview
- Phase
- Phase 3
- Intervention
- Acetaminophen
- Conditions
- Post Operative Pain
- Sponsor
- NYU Langone Health
- Locations
- 1
- Primary Endpoint
- Pain using the visual analogue scale
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1000 Mg Acetaminophen
Acetaminophen will be given 24 hours before surgery
Intervention: Acetaminophen
Placebo
A sugar pill will be given 24 hours before the scheduled surgery.
Intervention: Placebo
Outcomes
Primary Outcomes
Pain using the visual analogue scale
Time Frame: 7 Days
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.
Narcotic Use
Time Frame: 7 Days
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.
Measure of time to discharge from the PACU
Time Frame: 7 Days
Time to discharge from the PACU
Morphine-equivalent dose consumption
Time Frame: 7 days
Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days
Measure of time to discharge from hospital
Time Frame: 7 Days
Time to discharge from the hospital