Postoperative Pain
Conditions
Brief summary
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
Interventions
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.
DRUGplacebo oral tablet
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.
DRUGAcetaminophen infusion
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.
DRUGPlacebo infusion
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Plan for open lumbar laminectomy and fusion surgery (1-3 levels) * Able to provide written informed consent * Must be able to swallow pills
Exclusion criteria
* Medical contraindications to acetaminophen * Emergency surgery * Chronic pain unrelated to surgery * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) Pain Intensity Scale Score | postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first additional opioid medication dose | After surgery until discharge, up to 10 days | Additional opioid pain medication as requested by the participant which is not scheduled |
| Length of Hospital Stay | After surgery until discharge, up to 10 days | — |
| Time to first ambulation after surgery | After surgery until discharge, up to 10 days | — |
| Quality of Life (EuroQol Questionaire) scale score | 48 hours, up to 1 month after surgery | Participants rate their quality of life using the EuroQol-5D-5L questionnaire (scale from 1 to 5, 1 = no problem, 5 = severe problem) |
| Change in Patient Global Assessment Scale Score | postoperative time intervals: 2 hours, 6 hours, 12 hours, 24 hours, 36 hours, 48 hours | 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) |
| Healthcare cost during admission | After surgery until discharge, up to 10 days | Cost of hospital stay obtained from participant's Electronic Medical Record |
| Number of participants with treatment-related hepatic toxicity | postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours | Values above the normal range for any of these four lab tests (AST, ALT, INR, bilirubin) will be considered hepatic toxicity |
| Number of participants with treatment-related skin rash | After surgery until discharge, up to 10 days, whichever is first | Per clinician assessment |
| Total number of additional opioid medication doses | After surgery until discharge, up to 10 days | Additional opioid pain medication as requested by the participant which is not scheduled |
| Cumulative opioid consumption | After surgery until discharge, up to 10 days | All opioid medications the patient takes after surgery will be converted to a morphine equivalent dose. |
Countries
United States
Outcome results
None listed