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Methadone Versus Placebo in Spine Fusion

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Pain

Intervention: Methadone (Drug); Saline (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Dhanesh K Gupta, M.D., Principal Investigator, Affiliation: Northwestern University Feinberg School of Medicine

Summary

What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid na´ve 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?

Clinical Details

Official title: The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study

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

Primary outcome: Hydromorphone postoperative opioid consumption (POC) at 48 hours

Secondary outcome:

Intraoperative remifentanil consumption

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

the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)

the number of occurrences of ventilatory depression during each evaluation interval

number of occurrences of nausea (resulting in treatment)

recorded emesis

occurrence of pruritus

Hydromorphone postoperative opioid consumption (POC)

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

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States
Additional Information

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Starting date: May 2010
Last updated: April 21, 2015

Page last updated: August 23, 2015

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