Ignite Creation Date:
2024-05-06 @ 1:45 PM
Last Modification Date:
2024-10-26 @ 1:19 PM
Study NCT ID:
NCT04115462
Status:
COMPLETED
Last Update Posted:
2020-07-08
First Post:
2019-09-30
Brief Title:
A Relation of Morphine-induced Itch and Pain Processing
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
Official Title:
A Mechanistic Study on Morphine-induced Orthogonal Neural Plasticity for Itch and Pain Processing in Humans a Relation of Morphine-induced Itch and Pain Processing
Status:
COMPLETED
Status Verified Date:
2020-07
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:
None
Brief Summary:
In This experiment the investigators would like to test the two following hypotheses regarding the mechanisms by which opioids cause itch
1 Opioids cause itch by a spinal disinhibition mechanism central nervous system CNS effect
2 Opioids cause itch through a mast cell-destabilizing effect leading to release of histamine and tryptase in the skin where itch is evoked peripheral mechanism
1 Opioids cause itch by a spinal disinhibition mechanism central nervous system CNS effect
2 Opioids cause itch through a mast cell-destabilizing effect leading to release of histamine and tryptase in the skin where itch is evoked peripheral mechanism
Detailed Description:
Intrathecal and orally administered opioids are heavily used for the treatment of several acute pain conditions However while opioids are effective analgesics for acute pain they are well-known to frequently cause itch pruritus as a side effect according with the two hypotheses stated above So far these two hypotheses have never been tested in humansThe present study describes a proposed study design for the purpose of confirming these two hypotheses in parallel in human subjects
Primary endpoints of the study
To evaluate changes itch and pain perception and superficial perfusion after each itch provocations
Secondary endpoints of the study
To evaluate the existence of a correlation between itch sensitization and analgesic efficacy
Primary endpoints of the study
To evaluate changes itch and pain perception and superficial perfusion after each itch provocations
Secondary endpoints of the study
To evaluate the existence of a correlation between itch sensitization and analgesic efficacy
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