Methadone Versus Placebo in Spine Fusion

NCT01125059 | Withdrawn

• 1 other identifier: STU00027431
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Postoperative Pain

Keywords

hydromorphone; lumbar posterior spinal fusion; lumbosacral spondylosis; Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Hydromorphone postoperative opioid consumption (POC) at 48 hours

  PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU

  48 hrs

Secondary Outcomes (8)

• Intraoperative remifentanil consumption

  the 8 hours prior to arrival in the recovery room

• pain at rest and with movement (numerical Rating Scale, NRS)

  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)

  1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

• the number of occurrences of ventilatory depression during each evaluation interval

  1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

• number of occurrences of nausea (resulting in treatment)

  1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

Study Arms (2)

Methadone Group

ACTIVE COMPARATOR

0.2 mg/kg IV methadone

Drug: Methadone

Placebo Group

PLACEBO COMPARATOR

5 mL saline bolus

Drug: Saline

Interventions

Methadone DRUG

0.2 mg/kg methadone IV bolus

Also known as: Dolophine

Methadone Group

Saline DRUG

3 mL saline IV bolus

Also known as: 0.9 NaCl

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

Pain, Postoperative

Interventions

Methadone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dhanesh K Gupta, M.D.

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology & Neurological Surgery

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 18, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

US (1)