Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04764825
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2021-02-18
Brief Title:
Methadone for Spinal Fusion Surgery
Sponsor:
Aarhus University Hospital
Organization:
University of Aarhus
Study Overview
Official Title:
Intraoperative Methadone for Postoperative Pain Management in Spinal Fusion Surgery a Prospective Double-blind Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METASPINE
Brief Summary:
A prospective double-blind randomized controlled trial investigating the effect of a single-dose of intraoperative methadone in patients undergoing spinal fusion
Detailed Description:
During early recovery after surgery intravenous opioids are typically administered to control the pain either as intermittent bolus administration by nursing staff or by a patient-controlled analgesia device Unfortunately repeated doses or boluses of shorter-acting opioids such as morphine oxycodone and fentanyl result in fluctuating blood concentrations with the inherent risk of only relatively brief periods of adequate pain relief Moreover the use of shorter-acting opioids increases the risk of opioid-associated side effects such as sedation nausea and vomiting An alternative approach to the postoperative use of shorter-acting opioids is therefore called for
In this respect methadone is an opioid with unique pharmacological properties that may be advantageous when applied intraoperatively A single-dose of this long acting opioid could provide a stable analgesia and potentially reduce the need for shorter-acting opioids
Method
150 patients will be included in an investigator-initiated prospective randomised double-blind controlled trial with three arms intervention arm 1 methadone administered at induction 015-02 mgkg ideal body weight Intervention arm 2 methadone administered in the end of surgery 015-02 mgkg ideal body weight Control arm morphine administered in the end of surgery 015-02 mgkg ideal body weight
The study will be GCP-monitored and is approved by the Danish Health and Medicines Authority 2020103115 and the Central Denmark Region Committees on Health Research Ethics 1-10-72-278-20
Objective The aim of this study is to investigate the effect of a single dose of intravenous intraoperative methadone on postoperative opioid consumption pain and side effects in patients scheduled for spinal fusion surgery A single dose of intravenous intraoperative morphine will be used as an active comparator
Hypothesis
Intravenous perioperative methadone reduces opioid consumption oral cumulative equivalent dose by 50 during the first 24 postoperative hours compared to intravenous morphineprimary outcome
Methadone reduces opioid consumption the first 6 postoperative hours compared to intravenous morphine
Methadone reduces pain in the affected areas at rest and during coughing1-72 hours after extubation compared to intravenous morphine
Methadone increases patient satisfaction with pain management during the first 24 postoperative hours compared to intravenous morphine on a Numerical Rating Scale NRS from 0 to 10 where 0 is unsatisfied and 10 is satisfied
The effects of methadone is attenuated when administered prior to surgical incision compared to administration in the end of surgery
The frequency of opioid-related side effects is similar in the groups compared
In this respect methadone is an opioid with unique pharmacological properties that may be advantageous when applied intraoperatively A single-dose of this long acting opioid could provide a stable analgesia and potentially reduce the need for shorter-acting opioids
Method
150 patients will be included in an investigator-initiated prospective randomised double-blind controlled trial with three arms intervention arm 1 methadone administered at induction 015-02 mgkg ideal body weight Intervention arm 2 methadone administered in the end of surgery 015-02 mgkg ideal body weight Control arm morphine administered in the end of surgery 015-02 mgkg ideal body weight
The study will be GCP-monitored and is approved by the Danish Health and Medicines Authority 2020103115 and the Central Denmark Region Committees on Health Research Ethics 1-10-72-278-20
Objective The aim of this study is to investigate the effect of a single dose of intravenous intraoperative methadone on postoperative opioid consumption pain and side effects in patients scheduled for spinal fusion surgery A single dose of intravenous intraoperative morphine will be used as an active comparator
Hypothesis
Intravenous perioperative methadone reduces opioid consumption oral cumulative equivalent dose by 50 during the first 24 postoperative hours compared to intravenous morphineprimary outcome
Methadone reduces opioid consumption the first 6 postoperative hours compared to intravenous morphine
Methadone reduces pain in the affected areas at rest and during coughing1-72 hours after extubation compared to intravenous morphine
Methadone increases patient satisfaction with pain management during the first 24 postoperative hours compared to intravenous morphine on a Numerical Rating Scale NRS from 0 to 10 where 0 is unsatisfied and 10 is satisfied
The effects of methadone is attenuated when administered prior to surgical incision compared to administration in the end of surgery
The frequency of opioid-related side effects is similar in the groups compared
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004826-47 | EUDRACT_NUMBER | None | None |