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Trial record 9 of 45 for:    Recruiting, Not yet recruiting, Available Studies | methadone

Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients (MAPS)

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ClinicalTrials.gov Identifier: NCT02989597
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Kobets, Montefiore Medical Center

Brief Summary:
Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion. Methadone is low cost, has a long half-life, has a convenient dosing schedule, has excellent oral bioavailability, and demonstrates slow onset to withdrawal. The literature comparing methadone to more commonly used post-operative narcotics demonstrates that it manages pain better, sustains consistent plasma concentrations, decreases overall narcotic requirement, results in no additional adverse events, and is safe, even in children, across several studies. Since the standard of care is non-methadone narcotic usage to manage the significant pain of complex spinal surgery cases, it is understandable that methadone could be a desirable alternative to promote sustained pain control and early ambulation in these patients. The goal of this study is to compare the effect of a single dose of methadone administered intraoperatively in enrolled spinal fusion patients to their historical controls given fentanyl and morphine, and determine if more sustained pain control during the first few days after surgery provides a better subjective experience for the patient with less pain, which allows them to ambulate and leave the hospital sooner than patients given a standard regimen.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Methadone Hydrochloride Other: Standard pain regimen Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Single-dose Intraoperative Methadone for Early Ambulation and Sustained Pain Control in Spinal Fusion Surgery Patients
Actual Study Start Date : July 29, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intra-operative Methadone Hydrochloride
Patient who will be given a single dose of intra-operative methadone, and having standard care otherwise
Drug: Methadone Hydrochloride
IV administration of methadone intra-operatively for a single dose

Active Comparator: Control
Patients administered standard of care
Other: Standard pain regimen
Control




Primary Outcome Measures :
  1. Pain rating [ Time Frame: Preoperatively ]
    Unit: number of rating on visual analogue scale

  2. Pain rating [ Time Frame: 4 hours after surgery ]
    Unit: number of rating on visual analogue scale

  3. Pain rating [ Time Frame: 8 hours after surgery ]
    Unit: number of rating on visual analogue scale

  4. Pain rating [ Time Frame: 12 hours after surgery ]
    Unit: number of rating on visual analogue scale

  5. Pain rating [ Time Frame: 16 hours after surgery ]
    Unit: number of rating on visual analogue scale

  6. Pain rating [ Time Frame: 20 hours after surgery ]
    Unit: number of rating on visual analogue scale

  7. Pain rating [ Time Frame: 24 hours after surgery ]
    Unit: number of rating on visual analogue scale

  8. Pain rating [ Time Frame: 28 hours after surgery ]
    Unit: number of rating on visual analogue scale

  9. Pain rating [ Time Frame: 32 hours after surgery ]
    Unit: number of rating on visual analogue scale

  10. Pain rating [ Time Frame: 36 hours after surgery ]
    Unit: number of rating on visual analogue scale

  11. Pain rating [ Time Frame: 40 hours after surgery ]
    Unit: number of rating on visual analogue scale

  12. Pain rating [ Time Frame: 44 hours after surgery ]
    Unit: number of rating on visual analogue scale

  13. Pain rating [ Time Frame: 48 hours after surgery ]
    Unit: number of rating on visual analogue scale

  14. Pain rating [ Time Frame: 52 hours after surgery ]
    Unit: number of rating on visual analogue scale

  15. Pain rating [ Time Frame: 56 hours after surgery ]
    Unit: number of rating on visual analogue scale

  16. Pain rating [ Time Frame: 60 hours after surgery ]
    Unit: number of rating on visual analogue scale

  17. Pain rating [ Time Frame: 64 hours after surgery ]
    Unit: number of rating on visual analogue scale

  18. Pain rating [ Time Frame: 68 hours after surgery ]
    Unit: number of rating on visual analogue scale

  19. Pain rating [ Time Frame: 72 hours after surgery ]
    Unit: number of rating on visual analogue scale

  20. Pain rating [ Time Frame: 76 hours after surgery ]
    Unit: number of rating on visual analogue scale

  21. Pain rating [ Time Frame: 80 hours after surgery ]
    Unit: number of rating on visual analogue scale

  22. Pain rating [ Time Frame: 84 hours after surgery ]
    Unit: number of rating on visual analogue scale

  23. Pain rating [ Time Frame: 88 hours after surgery ]
    Unit: number of rating on visual analogue scale

  24. Pain rating [ Time Frame: 92 hours after surgery ]
    Unit: number of rating on visual analogue scale

  25. Pain rating [ Time Frame: 96 hours after surgery ]
    Unit: number of rating on visual analogue scale


Secondary Outcome Measures :
  1. Time to ambulation [ Time Frame: Immediately postoperatively until ambulation, On average 3-4 days ]
    Unit: days. Assessments of patients' time to ambulatation

  2. Time to discharge from hospital [ Time Frame: Immediately postoperatively until patient discharge, on average 1 week, up to 1 month ]
    Unit: days. Measured at patient discharge

  3. Narcotic usage in the hospital [ Time Frame: Intraoperatively until patient discharge, on average 1 week, up to 1 month ]
    Unit: mg. Amount of narcotic used intra-operatively until study completion (patient discharge)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meets age criteria, age between 18-80
  • Undergoing lumbar fusion surgery, one or two spinal levels
  • ASA grades I-III

Exclusion Criteria:

  • Patient outside of age criteria
  • Renal failure requiring dialysis
  • Serum creatinine greater than 2.0
  • Hepatic dysfunction with liver function tests greater than twice the upper limit
  • Pulmonary disease requiring home oxygen therapy
  • Obstructive sleep apnea
  • Severe heart disease
  • Allergy to methadone, morphine, or fentanyl
  • Recent or distant history of opioid abuse
  • Poorly managed psychiatric illness
  • Known history of alcohol abuse
  • Morbid obesity (body mass index > 50 kg/m2)
  • Treatment with other NMDA receptor antagonists
  • Prolonged QTc on pre-operative EKG,
  • Refusal or inability to sign the consent form
  • Current use of HIV-1 protease inhibitors, erythromycin, ketoconazol, erifabutin, carbamazepine, phenytoin, phenobarbital, St. John's Wort, fluconazole, fluvoxamine, fluoxetine, paroxetine
  • Grapefruit juice intake within the last week

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): NCT02989597


Contacts
Contact: Andrew J Kobets, MD 7189306490 akobets@montefiore.org
Contact: Merritt D Kinon, MD 7189207400 Mkinon@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
The Bronx, New York, United States, 10467
Contact: Merritt Kinon, MD    718-920-7467    Mkinon@montefiore.org   
Contact: Andrew J Kobets, MD    7189207400    Akobets@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Andrew J Kobets, MD Department of Neurological Surgery, Albert Einstein School of Medicine/Montefiore Medical Center

Publications:

Responsible Party: Andrew Kobets, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02989597     History of Changes
Other Study ID Numbers: 2016-6985
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Methadone
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents