Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Acetaminophen 1000mg | Active Comparator | Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery |
|
| Intravenous Acetaminophen 1000mg | Experimental | Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen Oral Tablet | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | postoperative time intervals: 2 hours (baseline), 6 hours, 12 hours, 24 hours, 36 hours, 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Atman Desai, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| placebo oral tablet | Drug | 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. |
|
| Acetaminophen infusion | Drug | 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. |
|
| Placebo infusion | Drug | 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. |
|
Participants rate their quality of life using the EuroQol-5D-5L questionnaire (scale from 1 to 5, 1 = no problem, 5 = severe problem) |
| 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. | After surgery until discharge, up to 10 days |
| Healthcare cost during admission | Cost of hospital stay obtained from participant's Electronic Medical Record | 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 | postoperative time intervals: 2 hours(baseline), 24 hours, 48 hours |
| Number of participants with treatment-related skin rash | Per clinician assessment | 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) | 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 | 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 | After surgery until discharge, up to 10 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |