Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Study Details
Study Description
Brief Summary
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.].
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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:
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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)
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Placebo Comparator: Intravenous (IV) Placebo IV Placebo arm |
Drug: Placebo
Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
Other Names:
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Experimental: IV Ketorolac IV Ketorolac arm |
Drug: Ketorolac
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.
Other Names:
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Experimental: IV Acetaminophen IV Acetaminophen arm |
Drug: Acetaminophen
Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Perioperative Opioid use [Hospital stay (2-4 days)]
Measure the impact of treatment on total opioid use during the hospital stay
Secondary Outcome Measures
- Opioid Use at 4-6 weeks [4-6 weeks]
Track total opioid use after discharge for the first 4-6 weeks
- Opioid Use at 3 months [3 months]
Track total opioid use after discharge for the first 3 months; assess for continued opioid use
- Opioid Use at 1 year [1 year]
Track total opioid use after discharge for the first 1 year; assess for continued opioid use
- Opioid Use at 2 years [2 years]
Track total opioid use after discharge for the first 2 years; assess for continued opioid use
- Numerical Pain rating scale [1 days and 3 days]
Validated pain scale; will be completed by patient
- Blinding assessment [3 days]
Ask patients what group they thought they were assigned to
- Pain satisfaction [3 days]
Ask patients if they were satisfied with their pain management (Likert scale)
- Brief Pain Inventory [1 day and 3 days]
Validated pain scale; will be completed by patients
- Opioid related side effects [Hospital Stay (1-4 days)]
Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded
- Opioid related symptom distress scale [1 day and 3 days]
Validated outcome instrument to assess opioid related distress
- Perioperative Complications [Hospital Stay (1-4 days)]
Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded
- Days to walk 50 ft with PT [Hospital Stay (1-4 days)]
Days needed to be able to walk 50ft with PT
- Length of stay [Hospital Stay (1-4 days)]
Will record date of discharge
- Veterans Rand - 12 [pre-operative]
Functional outcome measure before surgery (global function)
- Oswestry Disability Index [pre-operative]
Functional outcome measure before surgery (low back pain)
- Veterans Rand - 12 [3 month follow up]
Functional outcome measure at 3 months (global function)
- Oswestry Disability Index [3 month follow up]
Functional outcome measure at 3 months (low back pain)
- Return to work [3 month follow up]
Record return to work
- Veterans Rand - 12 [1 year follow up]
Functional outcome measure at 1 year (global function)
- Oswestry Disability Index [1 year follow up]
Functional outcome measure at 1 year (low back pain)
- Return to work [1 year follow up]
Record return to work
- Numerical Pain rating scale [1 year follow up]
Validated pain scale; will be completed by patient
- Veterans Rand - 12 [2 year follow up]
Functional outcome measure at 2 years (global function)
- Oswestry Disability Index [2 year follow up]
Functional outcome measure at 2 years (low back pain)
- Return to work [2 year follow up]
Record return to work
- Numerical Pain rating scale [2 year follow up]
Validated pain scale; will be completed by patient
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-75
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Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach
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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:
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Documented allergy to NSAIDs or Acetaminophen
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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
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Current smokers (quite date < 30 days ago)
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Revision for pseudarthrosis
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Patients who are unable to physically or mentally provide consent to the study procedures.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital for Special Surgery | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Hospital for Special Surgery, New York
Investigators
- Study Director: Evangelia Zgonis, Research Manager for Spine Research
- Principal Investigator: Harvinder Sandhu, MD, Associate Professor of Orthopedic Surgery
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2014-333