Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570577
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Opioid Sparing Effect of an ISP Nerve Block on Post-Op Pain Control in Posterior Cervical Spine Fusion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Opioid Sparing Effect of an Inter-semispinalis Plane Block on Postoperative Pain Control in Posterior Cervical Spine Fusion Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
Participants who have a surgical procedure called Posterior Cervical neck Spine Fusion will normally need pain medication to relieve post operative pain This usually includes opioid medications In this study the consented participant may receive a nerve block procedure in addition to the pain relieving medication There is a fifty-fifty chance to receive the nerve block The goal is to see if the nerve block group needs less opioid medication has lower pain scores and is discharged from the hospital sooner
Detailed Description:
The purpose of this research study is to evaluate the opioid-sparing effect of the use of an Inter-semispinalis plane ISP block after posterior cervical spine fusion surgery
Posterior cervical fusion PCF is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain Uncontrolled pain can result in a delay in recovery and discharge Additionally high doses of opioids carry the risk of opioid dependence and other side effects include nausea vomiting sedation and in rare cases respiratory depression For all of the above reasons reducing the use of opioids is of utmost importance
Nerve blocks are one alternative to opioid use The ISP block is a procedure described in 2017 it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck bilaterally to block the nerves that run in this plane It is done under ultrasound guidance and although a limited number of studies have shown promise more data on its safety and efficacy are needed The addition of Dexamethasone to local anesthetics in nerve blocks resulted in significant prolongation of the analgesia
Posterior cervical fusion PCF is a painful procedure that often requires the use of high doses of opioids to minimize postoperative pain Uncontrolled pain can result in a delay in recovery and discharge Additionally high doses of opioids carry the risk of opioid dependence and other side effects include nausea vomiting sedation and in rare cases respiratory depression For all of the above reasons reducing the use of opioids is of utmost importance
Nerve blocks are one alternative to opioid use The ISP block is a procedure described in 2017 it is a relatively simple procedure that entails injecting local anesthetic between two muscles in the back of the neck bilaterally to block the nerves that run in this plane It is done under ultrasound guidance and although a limited number of studies have shown promise more data on its safety and efficacy are needed The addition of Dexamethasone to local anesthetics in nerve blocks resulted in significant prolongation of the analgesia
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