Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454259
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2007-03-29
Brief Title:
Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Fentanyl Ultra Low Doses Effects on Human Volunteers Nociceptive Threshold Towards a Simple Pharmacological Test Able to Predict Pain Vulnerability Post Operative Hyperalgesia Development Risk
Status:
COMPLETED
Status Verified Date:
2007-03
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:
FENTANULD
Brief Summary:
Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic pain Opioid are parts of pain sensitization processes but remain absolutely necessary in the intraoperative period NMDA receptor antagonists succeed in reducing this pain sensitization process Recent studies show that in pain and opioid-experienced rats POER fentanyl ultra low doses do not induce analgesia as observed in naive rats but hyperalgesia This is the first demonstration that a drug can induce opposite effect depending on individual history We also observed a strong correlation between this hyperalgesic response in POER and the intensity of hyperalgesia they develop later after inflammatory or surgical pain The main aim of this study is to measure the dose effect response to fentanyl ultra low doses on human volunteers nociceptive threshold to determine if such an opposite response profile can be revealed
Detailed Description:
Principal Objective Evaluate fentanyl ultra low doses effects on human volunteers nociceptive threshold depending on their prior pain and opioid experience
Secondary Objective Confirm the innocuousness of this test the 3 ultra low doses used in this trial will be 10 to 1000 fold lower than low doses use for anesthesia and analgesia and to find the fentanyl ultra low dose that could be used to develop a pain sensitisation predictive test
Study design Bicentric prospective randomized double-blind study
Inclusion criteria
In both groups
18-40 years old male volunteer
weight 60 to 85 kg
ASA score 1
Informed consent obtained from the patient
Gender Male
In operated group
- At least one history of peripheral surgery under general anesthesia with opioid in the past five years
Exclusion criteria
In both groups
The patient do not accept inclusion to the study
Drug or alcohol abuse history
Chronic use of analgesic drugs or history of chronic pain
Analgesic or opioid consumption within the 12hs preceding the fentanyl or placebo injection
Neurological andor psychiatric disorder inability to give informed consent
Psychological trauma within the two year preceding the inclusion
Any contraindication to fentanyl use
Use of any medication interacting with fentanyl
Exclusion period from the national healthy volunteer register
Gender Female
In healthy group
- Any history of general anesthesia or surgery
Study plan comparing two groups that only defer by their surgical and opioid prior experience and will receive three fentanyl ultra low doses 10 to 1000 fold lower than low doses use for anesthesia and analgesia and placebo cross over administration one week wash out period
Number of subjects 48
Secondary Objective Confirm the innocuousness of this test the 3 ultra low doses used in this trial will be 10 to 1000 fold lower than low doses use for anesthesia and analgesia and to find the fentanyl ultra low dose that could be used to develop a pain sensitisation predictive test
Study design Bicentric prospective randomized double-blind study
Inclusion criteria
In both groups
18-40 years old male volunteer
weight 60 to 85 kg
ASA score 1
Informed consent obtained from the patient
Gender Male
In operated group
- At least one history of peripheral surgery under general anesthesia with opioid in the past five years
Exclusion criteria
In both groups
The patient do not accept inclusion to the study
Drug or alcohol abuse history
Chronic use of analgesic drugs or history of chronic pain
Analgesic or opioid consumption within the 12hs preceding the fentanyl or placebo injection
Neurological andor psychiatric disorder inability to give informed consent
Psychological trauma within the two year preceding the inclusion
Any contraindication to fentanyl use
Use of any medication interacting with fentanyl
Exclusion period from the national healthy volunteer register
Gender Female
In healthy group
- Any history of general anesthesia or surgery
Study plan comparing two groups that only defer by their surgical and opioid prior experience and will receive three fentanyl ultra low doses 10 to 1000 fold lower than low doses use for anesthesia and analgesia and placebo cross over administration one week wash out period
Number of subjects 48
Study Oversight
Has Oversight DMC:
None
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?:
None