Use of Local Intraoperative Steroid in MIS TLIF

November 18, 2020 updated by: Kern Singh, Rush University Medical Center

Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion

The purpose of this study is to determine if the frequency and duration of postoperative pain are improved in participants receiving a local steroid injection (methylprednisolone) plus a systemic (intravenous (IV, by vein)) steroid (dexamethasone) when compared to those receiving a systemic (IV) steroid (dexamethasone) alone. Both of these steroid injections are already currently used at Rush and are considered standard of practice. It is well established that steroids have an anti-inflammatory (decreased swelling) effect on the soft tissue and it is routinely used in many types of surgery, but it is not known whether two steroids are better than one. The medications provided in this study are approved by the Food and Drug Administration (FDA).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain is a well-known complication following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). It has been found that up to 40% of lumbar spinal patients will have either recurrent or persistent postoperative pain. Several studies have demonstrated reduced patient reported pain scores following steroid administration. However, few studies have investigated intraoperative local injection of corticosteroid at the surgical site in an effort to reduce the incidence and duration of postoperative pain for MIS TLIF patients.

The purpose of this study is to determine if the incidence and duration of postoperative pain is improved in participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone undergoing MIS TLIF.

The investigators hypothesize that participants undergoing MIS TLIF who receive local methylprednisolone along with the systemic dexamethasone will have:

  1. Reduced incidence and duration of postoperative pain compared to participants receiving only systemic dexamethasone.
  2. Shorter hospital stay compared to participants receiving only systemic dexamethasone.
  3. Better short- and long-term outcomes compared to participants receiving only systemic dexamethasone

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 3

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing a primary 1- to 2-level MIS TLIF
  • Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
  • Patients able to provide informed consent

Exclusion Criteria:

  • Allergies or other contraindications to medicines in the protocol including:

    (a) Existing history of gastrointestinal bleeding

  • Current Smokers
  • Lumbar spine trauma
  • Bilateral cages
  • Lack of consent

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
Drug: Dexamethasone
Administration of 10mg Dexamethasone IV intraoperatively
Drug: Methylprednisolone
Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
Placebo Comparator: IV dexamethasone
Standard systemic (IV) dexamethasone only
Drug: Dexamethasone
Administration of 10mg Dexamethasone IV intraoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 2 years postoperative
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
2 years postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative adverse events
Time Frame: 1 week postoperative
Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
1 week postoperative
Physical Functioning
Time Frame: 2 years postoperative
Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
2 years postoperative
Disability
Time Frame: 2 years postoperative
Oswestry Disability Index score as compared to preoperative score
2 years postoperative
General health status
Time Frame: 2 years postoperative
Short Form-12 Survey scores as compared to preoperative value
2 years postoperative
Narcotic Consumption
Time Frame: 1 week postoperative
The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
1 week postoperative
Length of Stay
Time Frame: 1 week postoperative
The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
1 week postoperative
Intra-operative adverse events
Time Frame: day of surgery
Blood loss, length of surgery, procedural details, complications
day of surgery

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

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 (Actual)

November 13, 2015

Primary Completion (Actual)

May 3, 2019

Study Completion (Actual)

May 3, 2019

Study Registration Dates

First Submitted

October 5, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (Actual)

October 12, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15052003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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