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

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02700451
Collaborator
(none)
300
1
3
84
3.6

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
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:

  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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:
  • Normal Saline
  • 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:
  • Toradol
  • 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:
  • Tylenol, Ofirmev
  • Outcome Measures

    Primary Outcome Measures

    1. Perioperative Opioid use [Hospital stay (2-4 days)]

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

    Secondary Outcome Measures

    1. Opioid Use at 4-6 weeks [4-6 weeks]

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

    2. Opioid Use at 3 months [3 months]

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

    3. Opioid Use at 1 year [1 year]

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

    4. Opioid Use at 2 years [2 years]

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

    5. Numerical Pain rating scale [1 days and 3 days]

      Validated pain scale; will be completed by patient

    6. Blinding assessment [3 days]

      Ask patients what group they thought they were assigned to

    7. Pain satisfaction [3 days]

      Ask patients if they were satisfied with their pain management (Likert scale)

    8. Brief Pain Inventory [1 day and 3 days]

      Validated pain scale; will be completed by patients

    9. Opioid related side effects [Hospital Stay (1-4 days)]

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

    10. Opioid related symptom distress scale [1 day and 3 days]

      Validated outcome instrument to assess opioid related distress

    11. 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

    12. Days to walk 50 ft with PT [Hospital Stay (1-4 days)]

      Days needed to be able to walk 50ft with PT

    13. Length of stay [Hospital Stay (1-4 days)]

      Will record date of discharge

    14. Veterans Rand - 12 [pre-operative]

      Functional outcome measure before surgery (global function)

    15. Oswestry Disability Index [pre-operative]

      Functional outcome measure before surgery (low back pain)

    16. Veterans Rand - 12 [3 month follow up]

      Functional outcome measure at 3 months (global function)

    17. Oswestry Disability Index [3 month follow up]

      Functional outcome measure at 3 months (low back pain)

    18. Return to work [3 month follow up]

      Record return to work

    19. Veterans Rand - 12 [1 year follow up]

      Functional outcome measure at 1 year (global function)

    20. Oswestry Disability Index [1 year follow up]

      Functional outcome measure at 1 year (low back pain)

    21. Return to work [1 year follow up]

      Record return to work

    22. Numerical Pain rating scale [1 year follow up]

      Validated pain scale; will be completed by patient

    23. Veterans Rand - 12 [2 year follow up]

      Functional outcome measure at 2 years (global function)

    24. Oswestry Disability Index [2 year follow up]

      Functional outcome measure at 2 years (low back pain)

    25. Return to work [2 year follow up]

      Record return to work

    26. Numerical Pain rating scale [2 year follow up]

      Validated pain scale; will be completed by patient

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Hospital for Special Surgery, New York
    ClinicalTrials.gov Identifier:
    NCT02700451
    Other Study ID Numbers:
    • 2014-333
    First Posted:
    Mar 7, 2016
    Last Update Posted:
    Apr 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Hospital for Special Surgery, New York
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 11, 2022