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Completed

NCT Number: NCT02700451

Post-op Acetaminophen vs 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.].

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ketorolac

Drug

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: Toradol

Acetaminophen

Drug

Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Other names: Tylenol, Ofirmev

Placebo

Drug

Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Other names: Normal Saline

Primary outcomes

  1. Perioperative Opioid Use

    Time frame: Hospital stay (2-4 days)

    Measure the impact of treatment on total opioid use during the hospital stay

Secondary outcomes

  1. Opioid Use at 4-6 Weeks

    Time frame: 4-6 weeks

    Track opioid use after discharge for the first 4-6 weeks

  2. Opioid Use at 3 Months

    Time frame: 3 months

    Track opioid use after discharge for the first 3 months; assess for continued opioid use

  3. Opioid Use at 1 Year

    Time frame: 1 year

    Track opioid use after discharge for the first 1 year; assess for continued opioid use

  4. Opioid Use at 2 Years

    Time frame: 2 years

    Track total opioid use after discharge for the first 2 years; assess for continued opioid use

  5. Numerical Pain Rating Scale

    Time frame: 1 days and 3 days

    Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level

  6. Brief Pain Inventory

    Time frame: 1 day and 3 days

    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.

  7. Opioid Related Side Effects

    Time frame: Hospital Stay (1-4 days)

    Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded

  8. Perioperative Complications - Drain Output

    Time frame: Hospital Stay (1-4 days)

    Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded

  9. Perioperative Complications - Transfusion Rate

    Time frame: Hospital Stay (1-4 days)

    Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded

  10. Days to Walk 50 ft With PT

    Time frame: Hospital Stay (1-4 days)

    Days needed to be able to walk 50ft with PT

  11. Length of Stay

    Time frame: Hospital Stay (1-4 days)

    Will record date of discharge

  12. Veterans Rand - 12

    Time frame: pre-operative

    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.

  13. Oswestry Disability Index

    Time frame: pre-operative

    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.

  14. Veterans Rand - 12

    Time frame: 3 month follow up

    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.

  15. Oswestry Disability Index

    Time frame: 3 month follow up

    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.

  16. Return to Work

    Time frame: 3 month follow up

    Record return to work

  17. Veterans Rand - 12

    Time frame: 1 year follow up

    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.

  18. Oswestry Disability Index

    Time frame: 1 year follow up

    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.

  19. Return to Work

    Time frame: 1 year follow up

    Record return to work

  20. Numerical Pain Rating Scale

    Time frame: 1 year follow up

    Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level

  21. Veterans Rand - 12

    Time frame: 2 year follow up

    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.

  22. Oswestry Disability Index

    Time frame: 2 year follow up

    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.

  23. Return to Work

    Time frame: 2 year follow up

    Record return to work

  24. Numerical Pain Rating Scale

    Time frame: 2 year follow up

    Validated pain scale; will be completed by patient Minimum Score: 0 & Maximum score 100 A lower score is representative of a low pain level

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2023
First posted
Mar 7, 2016
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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