Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery

Study Overview
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Brief Summary
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Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.

Official Title
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Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Treatment in Spinal Surgery

Conditions
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Lumbar; Injury

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing 1-2 levels primary spine surgery ≥18 years old Exclusion Criteria: Chronic opiate users More than 3 levels or revision spine surgery Liver disease patients include elevated LFT, hepatitis A, hepatitis B or hepatitis C, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s) Allergy/hypersensitivity to acetaminophen Patients that have used acetaminophen during the 24 hours before their scheduled surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Acetaminophen<br>Intravenous acetaminophen (1000mg) will be administered within 30 minutes of skin closure. | Drug: Acetaminophen<br>* Patients will received 1000mg of intravenous acetaminophen within 30 minutes of skin closure.<br>* Other names: Tylenol;|
| Placebo Comparator: Intravenous Placebo<br>Intravenous normal saline will be administered within 30 minutes of skin closure. | Drug: Placebo<br>* Patients will received 1000mg of normal saline within 30 minutes of skin closure.<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst pain score in the post-anesthesia care unit | The primary outcome will assess worst pain score at the time the patient is ready for post anesthesia care unit discharge using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 to 10, with higher values reporting more pain. | Time of postoperative care unit discharge readiness, approximately 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores | Pain scores will be collected for the first 72 hours or up until discharge, whichever comes first, using clinically documented nursing pain scores. Values will be collected on a scale from 0 to 10 with higher values indicating increased (worst) pain. | Postoperatively until 72 hours or discharge, approximately three days | 
| Intraoperative opioid consumption | Total cumulative morphine equivalents will be reported while the patient is in the operating room. | Intraoperatively | 
| Postoperative opioid consumption in the post anesthesia care unit | Total cumulative morphine equivalents will be reported while the patient is in the post anesthesia care unit. | Postoperatively until time of PACU discharge, approximately 3 hours. | 
| Postoperative opioid consumption after discharge from the postoperative care | Total cumulative morphine equivalents will be reported starting from the time the patient is discharged from the post anesthesia care unit until they are discharged from the hospital. | Time of discharge from the postoperative care unit until discharge from the hospital, an average of two days | 
| Time to rescue analgesia | The time to rescue analgesia (in minutes) will be assessed. | Postoperatively until discharge, an average of two days | 
| Patient satisfaction | Satisfaction with the patient's pain treatment in the hospital will be assessed at the time the patient is ready for discharge from the post anesthesia care unit using the Revised American Pain Society Patient Outcome Questionnaire. This scale ranges from 0 (extremely dissatisfied) to 10 (extremely satisfied). | Time of postoperative care unit discharge readiness, approximately 3 hours. | 
| Length of hospital stay | Length of hospital stay (in days) will be reported. | Postoperatively until discharge, an average of two days |