Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT01125059
Status:
WITHDRAWN
Last Update Posted:
2015-04-22
First Post:
2010-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methadone Versus Placebo in Spine Fusion
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study
Status:
WITHDRAWN
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to fulfill recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: