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Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion

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ClinicalTrials.gov Identifier: NCT02061774
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Brief Summary:
The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Acetaminophen Drug: Placebo comparator Phase 4

Detailed Description:

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. The advantages of intravenous acetaminophen are well known in the literature and its opioid-sparing effects have been documented in multiple surgical studies.

Multimodal regimens are now being advocated in the literature to decrease opioid use (8, 23). This is especially significant in spine surgery patients who often have chronic pain requiring long-term use of these habit-forming drugs as well as in patients who may not be able to tolerate opiods due to health status.

To our knowledge there are no studies done in the U.S. on the opioid sparing and pain reducing effects of intravenous acetaminophen on patients undergoing elective minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. Investigating intravenous acetaminophen, particularly its pain reducing and opioid sparing effects, may give surgeons another medication for use in a multimodal approach to pain.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen:
Study Start Date : October 2013
Actual Primary Completion Date : January 11, 2018
Actual Study Completion Date : January 11, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: acetaminophen
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
Drug: Acetaminophen
1 gram of intravenous Acetaminophen
Other Name: Tylenol

Placebo Comparator: PlaceboComparator
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Drug: Placebo comparator
placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Other Name: placebo




Primary Outcome Measures :
  1. VAS [ Time Frame: Q4 x 24 hours ]
    The Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings


Secondary Outcome Measures :
  1. Sedation [ Time Frame: 4-hr intervals for a 24-hr period ]
    Sedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli.

  2. Vital signs [ Time Frame: 4-hour intervals (+/- 30 minutes) for 24-hrs ]
    Routine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate. Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor.



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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:

  • Age > 18 years old
  • Being scheduled to have elective primary minimally invasive 1 or 2 level transforaminal lumbar laminectomy interbody fusion
  • ASA I, II, or III
  • Informed consent form signed

Exclusion Criteria:

  • Anyone weighing less than 50kg (as this would require a dosing change).
  • Hypersensitivity or contraindication to intravenous acetaminophen or opioids
  • Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl
  • Impairment of liver function-- defined as the inability to receive intravenous acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart
  • Mental retardation recorded as a diagnosis in the patient's chart
  • History of chronic pain (defined as currently receiving treatment from a specialist for pain)
  • History of pain recalcitrant to intravenous morphine
  • Impaired kidney function (defined as creatinine > 1.5)
  • Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of

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): NCT02061774


Locations
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United States, Texas
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79430
Sponsors and Collaborators
Texas Tech University Health Sciences Center
Investigators
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Principal Investigator: Jason Felton, MD TTUHSC department of Surgery

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Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT02061774     History of Changes
Other Study ID Numbers: L14-015
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No data will be shared
Keywords provided by Texas Tech University Health Sciences Center:
acetaminophen in transforaminal lumbar interbody fusion
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics