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Methadone Versus Placebo in Spine Fusion

Primary Purpose

Postoperative Pain

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Methadone

Saline

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring hydromorphone, lumbar posterior spinal fusion, lumbosacral spondylosis, Spinal Fusion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methadone Group

Placebo Group

Arm Description

0.2 mg/kg IV methadone

5 mL saline bolus

Outcomes

Primary Outcome Measures

Hydromorphone postoperative opioid consumption (POC) at 48 hours

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

Secondary Outcome Measures

Intraoperative remifentanil consumption

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)

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)

PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU

Full Information

NCT ID

NCT01125059

First Posted

May 11, 2010

Last Updated

April 21, 2015

Sponsor

Northwestern University

Collaborators

Northwestern University Feinberg School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01125059

Brief Title

Methadone Versus Placebo in Spine Fusion

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Unable to fulfill recruitment

Study Start Date

May 2010 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Northwestern University Feinberg School of Medicine

4. Oversight

Data Monitoring Committee

5. Study Description

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?

Detailed Description

Hypothesis: 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. We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methadone Group

Arm Type

Active Comparator

Arm Description

0.2 mg/kg IV methadone

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

5 mL saline bolus

Intervention Type

Drug

Intervention Name(s)

Methadone

Other Intervention Name(s)

Dolophine

Intervention Description

0.2 mg/kg methadone IV bolus

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

0.9 NaCl

Intervention Description

3 mL saline IV bolus

Primary Outcome Measure Information:

Title

Hydromorphone postoperative opioid consumption (POC) at 48 hours

Description

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

Time Frame

48 hrs

Secondary Outcome Measure Information:

Title

Intraoperative remifentanil consumption

Description

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)

Time Frame

the 8 hours prior to arrival in the recovery room

Title

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

Time Frame