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The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy

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ClinicalTrials.gov Identifier: NCT02252432
Recruitment Status : Enrolling by invitation
First Posted : September 30, 2014
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE September 26, 2014
First Posted Date  ICMJE September 30, 2014
Last Update Posted Date February 11, 2022
Actual Study Start Date  ICMJE February 2013
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Opioid consumption obtained from the recorded data [ Time Frame: 6 weeks ]
    Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires approximately day 1-3 and 6 weeks after surgery).
  • Postoperative pain using a Verbal Rating Scale [ Time Frame: 6 weeks ]
    Postoperative measured at PACU, Day 1-3 and 6 weeks after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2014)
  • Nausea and vomiting will be measured with follow up [ Time Frame: 6 weeks ]
    Postoperative nausea and vomiting using a Verbal Rating Scale (0-10) at PACU, Day 1-3 and 6 weeks after surgery
  • Constipation (Ileus) will be measured with follow up [ Time Frame: 6 weeks ]
    Day 1-3 and 6 weeks after surgery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
Official Title  ICMJE Intraoperative Ketamine and Methadone for Laminectomy: Effect on Recovery, Postoperative Pain, and Opioid Requirements
Brief Summary The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar, an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of both drugs may be able to provide better control of pain after lumbar surgery.
Detailed Description

During and after the surgery, patients undergoing surgery most likely need narcotics (opioids) that can cause side effects such as drowsiness and constipation. This can delay your recovery. The investigator would like to determine if the intraoperative use of ketamine and methadone will provide better pain control and reduce the use of narcotic painkiller medications (analgesics) after lumbar surgery as compared to either drug (ketamine or methadone) alone.

Ketamine is used to help to reduce the amount of the commonly used intravenous anesthetic drugs, minimize heart rate and blood pressure instability during surgery, and to improve outcomes after surgery (e.g. less pain, less constipation, less nausea and vomiting after surgery, faster return of bowel function and shortened length of hospital stay).

Ketamine is approved by the U.S. Food and Drug Administration (FDA) to be used: as an anesthetic and analgesic (painkiller). Ketamine is an "adjuvant," which is a drug that may increase the effectiveness or strength of other drugs when given at the same time. Ketamine is administered as an adjuvant during anesthesia to produce anesthetic and analgesic-sparing effects (reduce the amount of anesthetics and narcotics-painkiller drugs), hemodynamic stability (to maintain the blood pressure and heart rate within normal rank) and side effect reduction (e.g., constipation, nausea and vomiting, itching, and urinary retention). Ketamine will be used as approved in this study. Ketamine is frequently used intraoperatively for pain control in patients undergoing spine surgery at our institution and is within the standard of care. The standard of care indicates that this is one possible method which has been demonstrated to be safe and effective for patient care. This may vary at different institutions.

Methadone is approved by the U.S. Food and Drug Administration (FDA) to be used: as an opioid pain reliever, similar to morphine, and for narcotic detoxification to reduce withdrawal symptoms. The dose of methadone that will be used in this study may be slightly higher than the approved dose depending on the subject's weight. However, this dose of methadone is frequently used intraoperatively for pain control in patients undergoing spine surgery at our institution and is within the standard of care. This may vary at different institutions.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Laminectomy
Intervention  ICMJE
  • Drug: Ketamine
    A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
  • Drug: Methadone
    A single dose of IV methadone (0.2 mg/kg) preinduction.
  • Drug: Ketamine + methadone
    Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
Study Arms  ICMJE
  • Active Comparator: Ketamine
    A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min))
    Interventions:
    • Drug: Methadone
    • Drug: Ketamine + methadone
  • Active Comparator: Methadone
    Will receive a single dose of IV methadone (0.2 mg/kg) preinduction
    Interventions:
    • Drug: Ketamine
    • Drug: Ketamine + methadone
  • Experimental: Ketamine + methadone
    Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
    Interventions:
    • Drug: Ketamine
    • Drug: Methadone
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: September 29, 2014)
114
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) IV and above
  • Intolerance, allergy, or contraindication to use of any medications used in this study
  • Significant coronary artery disease (abnormal stress test, myocardial infarction

    • within the last 3 months)
  • Increased intraocular pressure (e.g., untreated glaucoma)
  • Uncontrolled hypertension (BP > 140/90)
  • Sleep apnea and currently on continuous positive airway pressure (CPAP)
  • Increased intracranial pressure or clinical signs thereof
  • History of intracranial surgery, stroke, or brain aneurysm
  • Cardiac arrhythmias particularly prolonged QT syndrome
  • Drugs known to cause prolonged qT: class (IA) antiarrhythmics (quinidine, procainamide, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
  • Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
  • Pregnant or lactating women
  • Emergent laminectomy
  • Those already receiving ketamine or methadone prior to surgery
  • Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
  • Chronic renal failure ( creatinine > 2.0 mg/dL)
  • Liver failure e.g., active cirrhosis
  • Alcohol or substance abuse within in the past 3 months
  • Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
  • Chronic obstructive pulmonary disease (COPD)/Hypercarbia
  • Restrictive lung disease (pulmonary fibrosis, myasthenia gravis)
  • Congestive heart failure
  • Thyroid disease
  • Organ transplant patients
  • Drugs/substances known to inhibit methadone metabolism: macrolide antibiotics e.g., erythromycin, cimetidine, astemizole, voriconazole, grapefruit juice
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02252432
Other Study ID Numbers  ICMJE Pro00030109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roya Yumul, M.D., PhD. Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date February 2022

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