Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes

Study Overview
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Brief Summary
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Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects. The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function [quicker ambulation with physical therapy (PT), earlier return to work, etc.].

Detailed Description
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Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows: Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the Opiate-Related Symptom Distress Scale (ORSDS) Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health Survey The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.

Official Title
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A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes

Conditions
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Lumbar Osteoarthritis, Spondylosis, Lumbar Disc Disease, Spinal Stenosis

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach No history of long term opioid use (daily or almost daily opioid use > 2 weeks) and not on opiates at time of presentation to clinic Exclusion Criteria: Documented allergy to NSAIDs or Acetaminophen History of: Peptic Ulcer Disease, Congestive heart failure, Chronic liver disease, Elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) greater than 1.5 times control, Bleeding disorder, Renal dysfunction (Serum creatinine > 1.5 mg/dL), Glucocorticoid use within 1 month of surgery Current smokers (quite date < 30 days ago) Revision for pseudarthrosis Patients who are unable to physically or mentally provide consent to the study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Intravenous (IV) Placebo<br>IV Placebo arm | Drug: Placebo<br>* Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.<br>* Other names: Normal Saline;|
| Experimental: IV Ketorolac<br>IV Ketorolac arm | Drug: Ketorolac<br>* Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.<br>* Other names: Toradol;|
| Experimental: IV Acetaminophen<br>IV Acetaminophen arm | Drug: Acetaminophen<br>* Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.<br>* Other names: Tylenol, Ofirmev;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Opioid Use | Measure the impact of treatment on total opioid use during the hospital stay | Hospital stay (2-4 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Use at 4-6 Weeks | Track opioid use after discharge for the first 4-6 weeks | 4-6 weeks | 
| Opioid Use at 3 Months | Track opioid use after discharge for the first 3 months; assess for continued opioid use | 3 months | 
| Opioid Use at 1 Year | Track opioid use after discharge for the first 1 year; assess for continued opioid use | 1 year | 
| Opioid Use at 2 Years | Track total opioid use after discharge for the first 2 years; assess for continued opioid use | 2 years | 
| Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | 1 days and 3 days | 
| Brief Pain Inventory | The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring. | 1 day and 3 days | 
| Opioid Related Side Effects | Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded | Hospital Stay (1-4 days) | 
| Perioperative Complications - Drain Output | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded | Hospital Stay (1-4 days) | 
| Perioperative Complications - Transfusion Rate | Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded | Hospital Stay (1-4 days) | 
| Days to Walk 50 ft With PT | Days needed to be able to walk 50ft with PT | Hospital Stay (1-4 days) | 
| Length of Stay | Will record date of discharge | Hospital Stay (1-4 days) | 
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | pre-operative | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | pre-operative | 
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | 3 month follow up | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | 3 month follow up | 
| Return to Work | Record return to work | 3 month follow up | 
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | 1 year follow up | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | 1 year follow up | 
| Return to Work | Record return to work | 1 year follow up | 
| Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | 1 year follow up | 
| Veterans Rand - 12 | The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a Physical Health Summary Measure {PCS-physical component score} and a Mental Health Summary Measure {MCS-mental component score}. Score range is 0 to 100, higher score denotes a better outcome. This score range apply to both PCS and MCS. | 2 year follow up | 
| Oswestry Disability Index | The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability. | 2 year follow up | 
| Return to Work | Record return to work | 2 year follow up | 
| Numerical Pain Rating Scale | Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level | 2 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IV acetaminophen, IV Ketorolac, Post-operative analgesia, Opioid use