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Trial record 4 of 1936 for:    ACETAMINOPHEN

IV vs Oral Acetaminophen in Spine Fusion Perioperative Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03020875
Recruitment Status : Enrolling by invitation
First Posted : January 13, 2017
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE July 5, 2016
First Posted Date  ICMJE January 13, 2017
Last Update Posted Date October 3, 2019
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
Visual Analog Scale (VAS) for back and legs [ Time Frame: Change from baseline VAS at 6 months postoperative ]
Self reported pain frequency and intensity at 24 hour postoperative intervals until patient is discharged, at 6 week and 6 month follow-up. The scale is scored on a 100 mm line, with 0 being no pain and 100 being worst pain imaginable.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2017)
  • Length of Stay (LOS) [ Time Frame: Immediate postoperative ]
    Measured in total hours until discharge from hospital
  • Opioid Equivalent Dosing during Hospital Stay [ Time Frame: Postoperative ]
    Measured every 24 hours postoperative until discharge from hospital
  • Time to Ambulation [ Time Frame: Immediate postoperative ]
    Measured in total hours postoperative until patient is ambulatory
  • Oswestry Disability Index Version 2.1 (ODI) [ Time Frame: Preoperative, 6 weeks and 6 months postoperative ]
  • Long Term Opioid Usage [ Time Frame: 6 months Postoperative ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2017)
  • Length of Stay (LOS) [ Time Frame: Immediate postoperative ]
    Measured in total hours until discharge from hospital
  • Opioid Equivalent Dosing during Hospital Stay [ Time Frame: Immediate postoperative ]
    Measured every 24 hours postoperative until discharge from hospital
  • Time to Ambulation [ Time Frame: Immediate postoperative ]
    Measured in total hours postoperative until patient is ambulatory
  • Oswestry Disability Index Version 2.1 (ODI) [ Time Frame: Preoperative, 6 weeks and 6 months postoperative ]
  • Long Term Opioid Usage [ Time Frame: 6 months Postoperative ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV vs Oral Acetaminophen in Spine Fusion Perioperative Care
Official Title  ICMJE Single-Center, Randomized Controlled Trial of Intravenous v Oral Acetaminophen Administration in Perioperative Care of 1 and 2 Level XLIFs Supplemented With Bilateral Pedicle Screw Stabilization: a Comparative Effectiveness Study
Brief Summary

The United States is currently experiencing an explosive opioid epidemic. In 2014 alone, 28,647 Americans died from an opioid associated overdose; the annual death toll has increased by over 300% since 2000. The epidemic poses a complex scenario for physicians administering treatment for postoperative pain, as opioids are key analgesic agents in treating moderate to severe pain. In order to reduce the patients risk for long term opioid use and the associated side effects, physicians have begun shifting to multimodal analgesic approaches to treat postoperative pain. These approaches have been found to be similarly efficacious, while also reducing opioid usage and associated side effects, such as: nausea, vomiting, and ileus.

This study proposes a multimodal analgesic approach, which the investigators believe will reduce short and long term opioid usage, the associated side effects, and the financial burden. Intravenous acetaminophen is an effective medication for both primary and adjunctive pain management, however its use is limited by a high cost to perceived benefit ratio. Oral acetaminophen is a relatively inexpensive option, although perhaps less effective than the IV option, and also often not feasible to utilize in the immediate post-operative period when patients are unable to safely swallow pills. The hypothesis of this investigation is to understand if adding intravenous acetaminophen to the perioperative care regimen after lumbar spinal surgery will result in improved pain management in the perioperative period while decreasing opioid usage and related complications.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multimodal Analgesic Approach
Intervention  ICMJE
  • Drug: Ofirmev
    Intravenously administered acetaminophen.
    Other Name: Intravenous Acetaminophen
  • Drug: Per Os Acetaminophen
    Orally administered acetaminophen.
Study Arms  ICMJE
  • Active Comparator: PO Acetaminophen

    Preop:

    Eligible patients will receive oral acetaminophen within 3 hours of OR start time.

    Postop:

    Eligible patients will be administered oral acetaminophen following 1 and 2 level LLIFs supplemented with instrumented posterior fusion to evaluate pain management outcomes. Dosing for the group will be the following:

    • Oral Acetaminophen 1,000 mg every 6 hours for 48 hours postoperative. Medication will be given at least 6 hours following initial preoperative dose of oral acetaminophen.

    Postop supplemental pain medications:

    All patients will receive a standardized hydromorphone IV-PCA order set for 24 hours postoperatively. The use of tramadol and tapentadol will specifically be discouraged due to challenges in determining morphine-equivalent dosing with these specific agents. Similarly, acetaminophen containing combination products (e.g. oxycodone/acetaminophen or hydrocodone/acetaminophen) will not be allowed due to overlap with the primary study medications.

    Intervention: Drug: Per Os Acetaminophen
  • Active Comparator: Intravenous Acetaminophen

    Preop:

    Eligible patients will receive IV acetaminophen within 3 hours of OR start time.

    Postop:

    Eligible patients will be administered IV acetaminophen following 1 and 2 level LLIFs supplemented with instrumented posterior fusion to evaluate pain management outcomes. Dosing for the group will be the following:

    • IV Acetaminophen 1,000 mg [100 ml] every 6 hours for 48 hours postoperative. Medication will be given at least 6 hours following initial preoperative dose of IV acetaminophen.

    Postop supplemental pain medications:

    All patients will receive a standardized hydromorphone IV-PCA order set for 24 hours postoperatively. The use of tramadol and tapentadol will specifically be discouraged due to challenges in determining morphine-equivalent dosing with these specific agents. Similarly, acetaminophen containing combination products (e.g. oxycodone/acetaminophen or hydrocodone/acetaminophen) will not be allowed due to overlap with the primary study medications.

    Intervention: Drug: Ofirmev
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 11, 2017)
166
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of spinal stenosis of the lumbar spine with degenerative spondylolisthesis
  • Skeletally mature adults between the ages of 18-85 years at the time of surgery
  • The greater of the patients right and left VAS leg pain, or back pain, score is > 40 mm on a 100 mm scale
  • Has attempted conservative therapy
  • Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures
  • Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study

Exclusion Criteria:

  • Any evidence of a prior/current fracture, compromised vertebra, current or past trauma, or tumor at affected level or the spinous processes at the adjacent levels
  • Revision of prior fusion attempt at the level being operated on
  • Cauda Equina Syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
  • Significant peripheral neuropathy or acute denervation secondary to radiculopathy, caused by conditions other than spinal stenosis
  • Significant peripheral vascular disease (diminished dornails pedis or tibial pulses)
  • Morbid obesity, defined as BMI > 40 kg/m2; or underweight, defined as BMI < 18.5 kg/m2
  • Active systematic or local infection
  • Active Viral Hepatitis (receiving medical treatment within 1 year); or any other acute hepatitis within the past 6 months
  • Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia
  • Insulin dependent diabetes mellitus or any other medical conditions that would represent a significant increase in surgical risk or interfere with normal healing
  • Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose for >1 month within last 12 months
  • History of Paget's disease, osteomalacia, or osteoporosis with a DEXA t-score less than or equal to -2.5
  • Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy >5 years
  • Any current history of substance abuse (e.g., recreational drugs, narcotics, or alcohol)
  • History of psychosocial disorders that could prevent accurate completion of self-reporting assessment scales
  • Previous known allergy to acetaminophen
  • Women who are pregnant or lactating
  • Patients involved in active litigation relating to his/her spinal condition
  • Patients taking >30mg/day of oral morphine sulfate, or the equivalent of this daily for more than 3 months
  • Patient is unable to ingest orally administered medication
  • Patient receiving autologous Iliac Crest bone graft (ICBG)
  • Known intolerance of or true allergy to hydromorphone or oxycodone.
  • History of moderate to severe Cirrhosis, defined as Child Pugh score of class B, C, or D
  • History of Hemochromatosis or Porphyria
  • Patient taking Isoniazid or barbiturates
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03020875
Other Study ID Numbers  ICMJE 2015-516
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Mallinckrodt
Investigators  ICMJE
Principal Investigator: Chad Craig, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP