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Trial record 56 of 1889 for:    ACETAMINOPHEN

The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion

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ClinicalTrials.gov Identifier: NCT03104816
Recruitment Status : Terminated (Could not get an approval from Department Reviewer for the study continuation.)
First Posted : April 7, 2017
Results First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eugenia Ayrian, University of Southern California

Brief Summary:

Simple explanation and rationale:

Recovery after spine surgery is usually accompanied by severe pain which has traditionally been managed with opioids. It is common practice to supplement opioid treatment with different classes of analgesics which work through alternative pain pathways and receptors in order to achieve an additive or synergistic effect while reducing the amount of opioids necessary for pain control.

Acetaminophen can be a beneficial supplemental analgesic to opioids for postoperative pain relief.

Intervention:

Patients will be randomized to either the treatment with IV acetaminophen (A), PO acetaminophen (B), or hydromorphone control group (C).

Objective/Purpose:

Primary objective is to determine the impact of administering a supplemental non-opioid analgesic drug such as IV or PO acetaminophen on total opioid dose administered over the postoperative period.

Secondary objectives include investigating the impact of IV/PO acetaminophen on the level of postoperative pain, patient satisfaction, and side effects secondary to opioids such as nausea, vomiting, pruritus, sedation, respiratory depression, ileus, and urinary retention, and PACU (postoperative care unit) discharge time.

Study population:

126 patients will be enrolled in the study (42 for group A, 42 for group B, and 42 for control group C).

Follow-up and Endpoints / Outcomes:

Postoperative assessments will be done at 0, 30, and 60 minutes, 6 hours, 12 hours and 24 hours after surgery. Patients will be evaluated for pain (using a numeric rating scale), total opioid consumption, and for opioid side effects including drowsiness (using the Ramsey sedation scale and the Aldrete score at the time of arrival to and discharge from recovery room), respiratory depression, nausea, vomiting, and pruritus. Patient satisfaction will also be assessed using a numeric rating scale.


Condition or disease Intervention/treatment Phase
Fusion of Spine, Lumbar Region Drug: Acetaminophen IV Soln 10 MG/ML Drug: Acetaminophen Drug: Hydromorphone Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion: a Prospective, Randomized Controlled Trial
Study Start Date : October 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetaminophen IV Soln 10 MG/ML (A)
Patients in group A will receive 1 g of IV acetaminophen 15 minutes prior to wound incision, and every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Drug: Acetaminophen IV Soln 10 MG/ML
Other Name: Ofirmev

Drug: Hydromorphone
Other Name: Dilaudid

Experimental: PO acetaminophen (B)
Patients in group B will receive 1 g of PO acetaminophen prior to surgery, and 1 g of oral acetaminophen every 4 to 6 hours postoperatively for a total of 4 grams in 24 hours.
Drug: Acetaminophen
Other Name: Tylenol

Drug: Hydromorphone
Other Name: Dilaudid

Active Comparator: Hydromorphone (control arm) (C)
Patients in the control arm (Group C) will not receive acetaminophen for 24 hours.
Drug: Hydromorphone
Other Name: Dilaudid




Primary Outcome Measures :
  1. Postoperative Opioid Use [ Time Frame: Within 24 hours after surgery ]
    Determine the impact of administering a supplemental non-opioid analgesic drug such as IV/oral acetaminophen on total opioid dose administered over the perioperative period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists) I-III patients scheduled for elective one or two level minimally invasive lumbar fusions

Exclusion Criteria:

  • Patients requiring surgery for neoplastic processes
  • Allergy to acetaminophen
  • Liver dysfunction and elevated Liver Function Tests (LFTs)
  • Alcohol or drug dependency
  • Mental retardation
  • Less than 50 kg of weight
  • regnant women
  • Patients requiring long-acting opioid pain management (including fentanyl patch, oxycontin, etc) for over 3 weeks immediately prior to surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104816


Locations
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United States, California
Keck Hospital of USC
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Eugenia Ayrian University of Southern California
  Study Documents (Full-Text)

Documents provided by Eugenia Ayrian, University of Southern California:

Publications:
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Responsible Party: Eugenia Ayrian, Associate Professor of Clinical Anesthesiology;Chief of Neuro Anesthesiology, University of Southern California
ClinicalTrials.gov Identifier: NCT03104816     History of Changes
Other Study ID Numbers: HS-15-00615
First Posted: April 7, 2017    Key Record Dates
Results First Posted: October 8, 2019
Last Update Posted: October 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will kept for a minimum of 3 years after the study is completed. All documents containing identifiers will be shredded. Electronic documents will be deleted.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eugenia Ayrian, University of Southern California:
Acetaminophen po
Acetaminophen IV
Pain management
minimally invasive lumbar fusions
Ofirmev
Analgesics
Opioid
Pain
Postoperative
Spinal
Additional relevant MeSH terms:
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Acetaminophen
Hydromorphone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants