Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF : Double Blinded, Randomized Control Trial (MIS-TLIF)

April 15, 2024 updated by: Potsawat Surabotsopon
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone group
Drug: Dexamethasone
long-acting corticosteroid IV route
Placebo Comparator: Normal saline group
Drug: Normal saline
normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of dexamethasone
Time Frame: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period
postoperative VAS score at rest and motion for back pain
24 hours, 2 weeks, 6 weeks, 12 weeks post operative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: 24 hours post operative period
rate of morphine usage for pain management
24 hours post operative period
Complication
Time Frame: 24 hours, 2 weeks, 6 weeks, 12 weeks post operative period
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
24 hours, 2 weeks, 6 weeks, 12 weeks post operative period
Fusion rate
Time Frame: 6months
To compare the fusion rates of the spinal bones
6months
Length of hospital stay
Time Frame: 1 year
To compare the length of hospital stays after surgery.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Potsawat Surabotsopon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSKC20222025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data request can be submitted 1 year after publication and available up to 2 years

IPD Sharing Time Frame

data request can be submitted 1 year after publication and available up to 2 years

IPD Sharing Access Criteria

access to IPD can be requested to the first researcher's email as noted in this form

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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