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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Withdrawn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
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
May 11, 2010
Last Updated
April 21, 2015
Sponsor
Northwestern University
Collaborators
Northwestern University Feinberg School of Medicine
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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
No

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
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
Title
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
Title
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
Title
number of occurrences of nausea (resulting in treatment)
Time Frame
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
Title
recorded emesis
Time Frame
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
Title
occurrence of pruritus
Time Frame
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
Title
Hydromorphone postoperative opioid consumption (POC)
Description
PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU
Time Frame
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanesh K Gupta, M.D.
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Methadone Versus Placebo in Spine Fusion

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