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Methadone Versus Placebo in Spine Fusion

This study has been withdrawn prior to enrollment.
(Unable to fulfill recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01125059
First Posted: May 18, 2010
Last Update Posted: April 22, 2015
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.
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Dhanesh Gupta, Northwestern University
  Purpose
What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine each day? What is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?

Condition Intervention
Postoperative Pain Drug: Methadone Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study

Resource links provided by NLM:


Further study details as provided by Dhanesh Gupta, Northwestern University:

Primary Outcome Measures:
  • Hydromorphone postoperative opioid consumption (POC) at 48 hours [ Time Frame: 48 hrs ]
    PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU


Secondary Outcome Measures:
  • Intraoperative remifentanil consumption [ Time Frame: the 8 hours prior to arrival in the recovery room ]
    intraoperative consumption of remifentanil--the amount of remifentanil used in the OR (i.e., the 2-8 hours prior to arrival in the recovery room)

  • pain at rest and with movement (numerical Rating Scale, NRS) [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ]
  • the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale) [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ]
  • the number of occurrences of ventilatory depression during each evaluation interval [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ]
  • number of occurrences of nausea (resulting in treatment) [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ]
  • recorded emesis [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ]
  • occurrence of pruritus [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ]
  • Hydromorphone postoperative opioid consumption (POC) [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs ]
    PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU


Enrollment: 0
Study Start Date: May 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methadone Group
0.2 mg/kg IV methadone
Drug: Methadone
0.2 mg/kg methadone IV bolus
Other Name: Dolophine
Placebo Comparator: Placebo Group
5 mL saline bolus
Drug: Saline
3 mL saline IV bolus
Other Name: 0.9 NaCl

Detailed Description:

Hypothesis:

  1. We hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg IV morphine a day undergoing lumbar interbody fusion.
  2. We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I, II, and III, male and non-pregnant female
  • English-speaking patients
  • Ages 18-75 years
  • Undergoing elective one or two level posterior lumbar interbody fusion

Exclusion Criteria:

  • Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.
  • Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin).
  • history of substance abuse at any time in the past
  • known QT prolongation
  • Non-elective operations (i.e., cancer or trauma)
  • severe hepatic impairment (serum albumin < 3.0 g/dL in the presence of a history of liver disease)
  • pregnancy
  • inability to operate a patient-controlled analgesia device
  Contacts and Locations
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): NCT01125059


Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Feinberg School of Medicine, Northwestern University
Investigators
Principal Investigator: Dhanesh K Gupta, M.D. Northwestern University Feinberg School of Medicine
  More Information

Publications:
Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA. 1995 Dec 20;274(23):1870-3. Review.
Upton RN, Semple TJ, Macintyre PE. Pharmacokinetic optimisation of opioid treatment in acute pain therapy. Clin Pharmacokinet. 1997 Sep;33(3):225-44. Review.
Taylor S, Kirton OC, Staff I, Kozol RA. Postoperative day one: a high risk period for respiratory events. Am J Surg. 2005 Nov;190(5):752-6.
Taylor S, Voytovich AE, Kozol RA. Has the pendulum swung too far in postoperative pain control? Am J Surg. 2003 Nov;186(5):472-5.
Liu N, Kuhlman G, Dalibon N, Moutafis M, Levron JC, Fischler M. A randomized, double-blinded comparison of intrathecal morphine, sufentanil and their combination versus IV morphine patient-controlled analgesia for postthoracotomy pain. Anesth Analg. 2001 Jan;92(1):31-6.
Joris J, Kaba A, Lamy M. Transition between anesthesia and post-operative analgesia: relevance of intra-operative administration of analgesics. Acta Anaesthesiol Belg. 2001;52(3):271-9. Review.
Carroll IR, Angst MS, Clark JD. Management of perioperative pain in patients chronically consuming opioids. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):576-91. Review.
Yaksh TL, Hua XY, Kalcheva I, Nozaki-Taguchi N, Marsala M. The spinal biology in humans and animals of pain states generated by persistent small afferent input. Proc Natl Acad Sci U S A. 1999 Jul 6;96(14):7680-6. Review.
Parker RK, Holtmann B, White PF. Effects of a nighttime opioid infusion with PCA therapy on patient comfort and analgesic requirements after abdominal hysterectomy. Anesthesiology. 1992 Mar;76(3):362-7.
Gourlay GK, Wilson PR, Glynn CJ. Pharmacodynamics and pharmacokinetics of methadone during the perioperative period. Anesthesiology. 1982 Dec;57(6):458-67.
Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51.
Egan TD, Huizinga B, Gupta SK, Jaarsma RL, Sperry RJ, Yee JB, Muir KT. Remifentanil pharmacokinetics in obese versus lean patients. Anesthesiology. 1998 Sep;89(3):562-73.
Lemmens HJ, Brodsky JB, Bernstein DP. Estimating ideal body weight--a new formula. Obes Surg. 2005 Aug;15(7):1082-3.
Bowdle TA, Even A, Shen DD, Swardstrom M. Methadone for the induction of anesthesia: plasma histamine concentration, arterial blood pressure, and heart rate. Anesth Analg. 2004 Jun;98(6):1692-7, table of contents.
Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709, table of contents.
van Dorp EL, Kest B, Kowalczyk WJ, Morariu AM, Waxman AR, Arout CA, Dahan A, Sarton EY. Morphine-6beta-glucuronide rapidly increases pain sensitivity independently of opioid receptor activity in mice and humans. Anesthesiology. 2009 Jun;110(6):1356-63. doi: 10.1097/ALN.0b013e3181a105de.

Responsible Party: Dhanesh Gupta, Associate Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01125059     History of Changes
Other Study ID Numbers: STU00027431
First Submitted: May 11, 2010
First Posted: May 18, 2010
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Dhanesh Gupta, Northwestern University:
hydromorphone
lumbar posterior spinal fusion
lumbosacral spondylosis
Spinal Fusion

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


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