Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864210
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2021-02-22
Brief Title:
Video-assisted Thoracoscopic Surgery - Exparel Study
Sponsor:
Rakesh Sondekoppam Vijayashankar
Organization:
University of Iowa
Study Overview
Official Title:
Analgesia for Video-assisted Thoracoscopic Surgeries A Comparison Between Intercostal Blocks With Liposomal Bupivacaine and Paravertebral Blocks With Plain Bupivacaine
Status:
RECRUITING
Status Verified Date:
2023-09
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:
Video-assisted thoracoscopic surgery VATS greatly decreased the number and types of surgery that required open thoracotomy Initially it was thought that VATS would lead to a reduction of respiratory problems and less acute pain in patients when compared to patients receiving an open thoracic surgery However for reasons not clearly understood a large number of patients who undergo VATS still experience moderate to severe post-surgical pain 1 Physicians are still faced with the challenge of providing care that will manage both the respiratory issues as well as manage acute pain The goal of this study is to find the most suitable regimen to effectively manage post-VATS-related pain
Detailed Description:
The promise was that video-assisted thoracoscopic surgery VATS would be associated with less severe pulmonary impairment and less acute post-operative pain compared to open thoracotomy However VATS can cause moderate to severe post-operative pain in a significant number of patients and the reason for this is not well understood In addition it has been found that post-surgical pain can be a strong predictor for the development of chronic pain Inadequate control of acute pain not only causes serious discomfort and significant respiratory problems but it may place this population of patients at greater risk of chronic pain and prescription opioid dependence
Current protocols to manage andor reduce VATS associated pain include combining the use of regional anesthesia techniques with opioid and non-opioid analgesics Recent studies have investigated the efficacy of intercostal blocks using liposomal bupivacaine after thoracic surgery However these studies lacked an active comparator population of patients
The study is designed as a prospective randomized study evaluating intercostal blocks using liposomal bupivacaine The control population of patients will be treated with a paravertebral block using plain bupivacaine
Current protocols to manage andor reduce VATS associated pain include combining the use of regional anesthesia techniques with opioid and non-opioid analgesics Recent studies have investigated the efficacy of intercostal blocks using liposomal bupivacaine after thoracic surgery However these studies lacked an active comparator population of patients
The study is designed as a prospective randomized study evaluating intercostal blocks using liposomal bupivacaine The control population of patients will be treated with a paravertebral block using plain bupivacaine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None