Viewing Study NCT06466941



Ignite Creation Date: 2024-07-17 @ 11:21 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06466941
Status: RECRUITING
Last Update Posted: 2024-07-15
First Post: 2024-06-14

Brief Title: Understanding the Acute Pain Phenotype in Patients Undergoing Surgery
Sponsor: Brigham and Womens Hospital
Organization: Brigham and Womens Hospital

Study Overview

Official Title: Impact of Patient Phenotypic Features on the Experience and Effectiveness of Regional Anesthesia and Postoperative Pain
Status: RECRUITING
Status Verified Date: 2024-07
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: The goal of this observational study is to learn about how regional anesthesia numbing medication affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain sleep issues and anxiety who are having surgery

The main questions are

1 Do psychosocial factors such as concerns about pain sleep anxiety affect the effectiveness of regional anesthesia
2 Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery
3 Do psychosocial factors and regional anesthesia affect development of chronic postsurgical pain
Detailed Description: A patients psychological profile importantly modulates pain severity and the overall experience and impact of pain For instance catastrophic thinking about pain including magnification rumination and helplessness is associated with both greater pain severity and impact

Over the years regional anesthesia has become an integral part of multimodal pain management for many surgeries Regional anesthesia epidural and peripheral nerve blocks to be associated with superior pain control reduced time to return of bowel function shorter intraoperative times fewer side effects and complications earlier ambulation and functional exercise capacity post-discharge lower in-hospital mortality reduced length-of-stay improved patient satisfaction and fewer readmissions

The investigators aim to use of validated psychosocial surveys and semi-structured interviews to understand the phenotype of patients who will benefit the most from regional anesthesia The investigators also aim to understand how different patient phenotypes and regional anesthesia affect perioperative opioid consumption and development of chronic postsurgical pain

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
2R35GM128691-06 NIH None None