Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367855
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-24
Brief Title:
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF Double Blinded Randomized Control Trial
Sponsor:
Potsawat Surabotsopon
Organization:
Thammasat University Hospital
Study Overview
Official Title:
Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF Double Blinded Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
MIS-TLIF
Brief Summary:
Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects aiming to enhance the effectiveness of surgery and improve patient outcomes
Detailed Description:
Surgery for spine fusion through a minimally invasive technique called MIS-TLIF has become increasingly popular nowadays due to various reasons such as lower blood loss and reduced need for blood transfusions less postoperative back pain and shorter surgical duration compared to the traditional technique known as TLIF However even after MIS TLIF patients still experience issues such as wound or back pain which can affect their physical activity and increase the risk of infection Prolonged hospital stays lead to resource wastage
In the Enhanced Recovery After Surgery ERAS program for spine surgery preoperative medication including Acetaminophen NSAIDs and Gabapentinoids is recommended to alleviate postoperative back pain However even after implementing ERAS patients undergoing MIS TLIF still experience pain suggesting that further pain reduction strategies are needed The use of Dexamethasone as preemptive medication has shown promising results in various surgeries with minimal side effects and a manageable cost Dexamethasone administered via injection has a longer duration of action compared to other steroids making it suitable for preemptive use
The main objective is to study the effectiveness of using Dexamethasone via intravenous injection before minimally invasive spine fusion surgery known as MIS-TLIF in reducing postoperative back pain
The secondary objectives are to compare the rate of morphine usage for pain management after surgery between two groups
To compare the side effects and adverse reactions of the medication such as nausea and vomiting surgical site infection rates and blood sugar levels post-surgery
To compare the fusion rates of the spinal bones To compare the length of hospital stays after surgery
In the Enhanced Recovery After Surgery ERAS program for spine surgery preoperative medication including Acetaminophen NSAIDs and Gabapentinoids is recommended to alleviate postoperative back pain However even after implementing ERAS patients undergoing MIS TLIF still experience pain suggesting that further pain reduction strategies are needed The use of Dexamethasone as preemptive medication has shown promising results in various surgeries with minimal side effects and a manageable cost Dexamethasone administered via injection has a longer duration of action compared to other steroids making it suitable for preemptive use
The main objective is to study the effectiveness of using Dexamethasone via intravenous injection before minimally invasive spine fusion surgery known as MIS-TLIF in reducing postoperative back pain
The secondary objectives are to compare the rate of morphine usage for pain management after surgery between two groups
To compare the side effects and adverse reactions of the medication such as nausea and vomiting surgical site infection rates and blood sugar levels post-surgery
To compare the fusion rates of the spinal bones To compare the length of hospital stays after surgery
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