Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 6:23 PM
Study NCT ID:
NCT06953635
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Versus Placebo in Open Ventral Hernia Repair
Sponsor:
University of Tennessee Graduate School of Medicine
Organization:
Study Overview
Official Title:
Quadratus Lumborum Blocks for Pain Control Following Open Ventral Hernia Repair: A Double Blinded Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
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:
VHR
Brief Summary:
The purpose of this study is to determine whether using a QL block is better than placebo (a look-alike substance that contains no drug) in lowering the amount of opioids you need for pain relief in the first 24 hours and if it improves your recovery following a ventral hernia repair.
Participants will be asked to complete a questionnaire before surgery and again at their 30-day follow up. You will also be asked to complete a pain diary 24 hours after surgery and attend a follow-up visit approximately 30 days after surgery.
The following information will be collected from you or your medical record:
1. Pain medications given to you during surgery.
2. Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency.
3. Pain levels during the first 24 hours after surgery.
4. Your total hospital length of stay after surgery.
5. Any complications that you may have experienced after surgery.
6. Demographic information, medical history as well as details about your hernia repair surgery.
Participants will be asked to complete a questionnaire before surgery and again at their 30-day follow up. You will also be asked to complete a pain diary 24 hours after surgery and attend a follow-up visit approximately 30 days after surgery.
The following information will be collected from you or your medical record:
1. Pain medications given to you during surgery.
2. Pain medications prescribed to you after surgery, including medication name, dose, units, and frequency.
3. Pain levels during the first 24 hours after surgery.
4. Your total hospital length of stay after surgery.
5. Any complications that you may have experienced after surgery.
6. Demographic information, medical history as well as details about your hernia repair surgery.
Detailed Description:
Quadratus Lumborum (QL) blocks have provided analgesia for abdominal surgery. These blocks involve ultrasound-guided local anesthetic injection deep into the anterior fascia of the quadratus lumborum into the thoracolumbar fascia, resulting in widespread abdominal and pelvic pain control. QL blocks extend that coverage from T4 to L1 in the paravertebral space. At this local institution, QL blocks have demonstrated the ability to provide complete sensory analgesia for most patients from T9-L1 up to an estimated 17 hours after surgery. Therefore the goal of this study is to evaluate the effectiveness of QL block in this patient population.
Study Oversight
Has Oversight DMC:
False
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?: