Methadone Versus Placebo in Spine Fusion

This study has been withdrawn prior to enrollment.
(Study design changed to broaden enrollment, include dose finding and pharmacodynamic information)
Sponsor:
Collaborator:
Feinberg School of Medicine, Northwestern University
Information provided by (Responsible Party):
Dhanesh Gupta, Northwestern University
ClinicalTrials.gov Identifier:
NCT01125059
First received: May 11, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose
  1. Research Question: 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?
  2. 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.

Condition Intervention
Postoperative Pain
Drug: Methadone
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 Northwestern University:

Primary Outcome Measures:
  • Hydromorphone postoperative opioid consumption (POC) at 48 hours [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • number of occurrences of nausea (resulting in treatment) [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ] [ Designated as safety issue: No ]
  • recorded emesis [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ] [ Designated as safety issue: No ]
  • occurrence of pruritus [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs ] [ Designated as safety issue: No ]
  • Hydromorphone postoperative opioid consumption (POC) [ Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs ] [ Designated as safety issue: No ]
    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 Drug: Methadone
0.2 mg/kg methadone IV bolus
Placebo Comparator: Placebo Group Drug: Saline
3 mL saline IV bolus

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Dhanesh Gupta, Associate Professor of Anesthesiology & Neurological Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01125059     History of Changes
Other Study ID Numbers: STU00027431
Study First Received: May 11, 2010
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 28, 2014