The goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Participants take 1000mg by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Participants take one placebo tablet (matchable to tylenol) by mouth every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Participants take 1000mg by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Stanford University
Stanford, California, United States
Numerical Rating Scale (NRS) Pain Intensity Scale Score
Mean pain intensity scores post-operatively using 11-point Numerical Rating Scale (NRS) (scale ranges from 0 to 10, and higher score means higher pain)
Time frame: postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Length of Hospital Stay
Time frame: After surgery until discharge, up to 10 days
Time to first ambulation after surgery
Time frame: After surgery until discharge, up to 10 days
Quality of Life (EuroQol Questionaire) scale score
Participants rate their quality of life using the EuroQol-5D-5L questionnaire (scale from 1 to 5, 1 = no problem, 5 = severe problem)
Time frame: 48 hours, up to 1 month after surgery
Cumulative opioid consumption
All opioid medications the patient takes after surgery will be converted to a morphine equivalent dose.
Time frame: After surgery until discharge, up to 10 days
Healthcare cost during admission
Cost of hospital stay obtained from participant's Electronic Medical Record
Time frame: After surgery until discharge, up to 10 days
Number of participants with treatment-related hepatic toxicity
Values above the normal range for any of these four lab tests (AST, ALT, INR, bilirubin) will be considered hepatic toxicity
Time frame: postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours
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Participants take 1000mg placebo by intravenous infusion over 15 minutes every 6 hours for a total of 8 doses (48 hours total) starting within 2 hours after their spine surgery.
Number of participants with treatment-related skin rash
Per clinician assessment
Time frame: After surgery until discharge, up to 10 days, whichever is first
Change in Patient Global Assessment Scale Score
Participants report their overall wellbeing as measured by 5-point Likert scale (ranging from 0-5, where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor)
Time frame: postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours
Time to first additional opioid medication dose
Additional opioid pain medication as requested by the participant which is not scheduled
Time frame: After surgery until discharge, up to 10 days
Total number of additional opioid medication doses
Additional opioid pain medication as requested by the participant which is not scheduled
Time frame: After surgery until discharge, up to 10 days