Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639438
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Sensory Outcomes in Active Substance Users
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Molecular and Behavioral Characterization of Post-Operative Sensory Outcomes in Active Substance Users
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence and severity of postoperative pain after spine surgery are notably high often requiring intensive management and potentially affecting the patients recovery satisfaction and long-term outcomes Post-operative pain is particularly difficult to manage in patients with substance use disorder likely due to a combination of withdrawal symptoms and molecular changes in the pain matrix Opiates are the leading cause of overdose related fatalities and carry a significant burden of substance related morbidity and mortality As over 80 of patients undergoing low-risk surgery receive opioid prescriptions the investigators aim to identify unique molecular characteristics of pain within current and previous opioid users which have been understudied in this context This study also seeks to understand the molecular mechanisms underlying worsened postoperative pain in patients with opioid use disorder OUD
Flow cytometry analysis of human serum will be done which will assess circulating immune cells that can contribute to exacerbated surgery site inflammation Spatial profiling of gene expression will be done in the dermis using Visium slide sequencing focusing on the interplay between nerve endings resident immune cells and supporting dermal cells all of which collectively contribute to the sensation pain Both the visual pain rating scale and McGill Pain Questionnaire will be used to comprehensively quantify pain outcomes during the participants postoperative recovery stay after surgery in an effort to better understand postoperative pain management with biomarkers of worsened postoperative pain
Flow cytometry analysis of human serum will be done which will assess circulating immune cells that can contribute to exacerbated surgery site inflammation Spatial profiling of gene expression will be done in the dermis using Visium slide sequencing focusing on the interplay between nerve endings resident immune cells and supporting dermal cells all of which collectively contribute to the sensation pain Both the visual pain rating scale and McGill Pain Questionnaire will be used to comprehensively quantify pain outcomes during the participants postoperative recovery stay after surgery in an effort to better understand postoperative pain management with biomarkers of worsened postoperative pain
Detailed Description:
The objective for this research are
1 Assess differences in pain reception in patients with existing or previous opioid use disorder versus controls after elective spine surgery via pain questionnaires at multiple time points during the perioperative care
2 Assess circulating immune signatures and neuropeptides associated with pain signaling before and after surgery in patients with and without OUD using flow cytometry and ELISA of patient serum
3 Assess molecular signatures of dermal cells and nerve endings patients with and without OUD using spatial transcriptomics on epidermis- and dermis-containing tissue samples from surgical incision
1 Assess differences in pain reception in patients with existing or previous opioid use disorder versus controls after elective spine surgery via pain questionnaires at multiple time points during the perioperative care
2 Assess circulating immune signatures and neuropeptides associated with pain signaling before and after surgery in patients with and without OUD using flow cytometry and ELISA of patient serum
3 Assess molecular signatures of dermal cells and nerve endings patients with and without OUD using spatial transcriptomics on epidermis- and dermis-containing tissue samples from surgical incision
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