Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Osteoarthritis (OA), Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/17/2018 |
| Start Date: | March 2016 |
| End Date: | August 2021 |
| Contact: | Jessica Andres Bergos, PhD |
| Email: | andresbergosj@hss.edu |
| Phone: | 917.260.4694 |
A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes
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.].
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.].
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.
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.
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.
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