Clinical trial NCT06367855: Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial
Official title: Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Spinal Stenosis Lumbar
Disc Degeneration
Disc Disease
Fusion of Spine
Surgery
Lead sponsor: Thammasat University Hospital
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age range: 50-80 years old.
* Undergoing MIS TLIF surgery at 1-2 spinal levels.

Exclusion Criteria:

* Previously undergone spine surgery.
* HbA1C greater than or equal to 7.5 mg%
* Allergic to all types of experimental medication.
* History of using systemic steroids.

Primary outcomes:
measure: effectiveness of dexamethasone
timeFrame: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period
Secondary outcomes:
measure: Morphine consumption
timeFrame: 24 hours post operative period
measure: Complication
timeFrame: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period
measure: Fusion rate
timeFrame: 6months
measure: Length of hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
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