Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery
- Conditions
- Postoperative Pain
- Interventions
- Drug: placebo oral tabletDrug: Placebo infusionDrug: Acetaminophen infusion
- Registration Number
- NCT07203079
- Lead Sponsor
- Stanford University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Plan for open lumbar laminectomy and fusion surgery (1-3 levels)
- Able to provide written informed consent
- Must be able to swallow pills
- Medical contraindications to acetaminophen
- Emergency surgery
- Chronic pain unrelated to surgery
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral Acetaminophen 1000mg Acetaminophen Oral Tablet Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery Oral Acetaminophen 1000mg Placebo infusion Participants take oral acetaminophen and placebo infusion for 48 hours within 2 hours after their spine surgery Intravenous Acetaminophen 1000mg placebo oral tablet Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery Intravenous Acetaminophen 1000mg Acetaminophen infusion Participants take acetaminophen infusion and oral placebo for 48 hours within 2 hours after their spine surgery
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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.
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
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)
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
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
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States
Stanford University🇺🇸Stanford, California, United States