ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Local Intraoperative Steroid in MIS TLIF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03308084
Recruitment Status : Active, not recruiting
First Posted : October 12, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kern Singh, Rush University Medical Center

October 5, 2017
October 12, 2017
October 12, 2017
November 13, 2015
July 28, 2017   (Final data collection date for primary outcome measure)
Postoperative Pain [ Time Frame: 2 years postoperative ]
Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
Same as current
No Changes Posted
  • Physical Functioning [ Time Frame: 2 years postoperative ]
    Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
  • Disability [ Time Frame: 2 years postoperative ]
    Oswestry Disability Index score as compared to preoperative score
  • General health status [ Time Frame: 2 years postoperative ]
    Short Form-12 Survey scores as compared to preoperative value
  • 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
  • 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.
  • Intra-operative adverse events [ Time Frame: day of surgery ]
    Blood loss, length of surgery, procedural details, complications
  • 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
Same as current
Not Provided
Not Provided
 
Use of Local Intraoperative Steroid in MIS TLIF
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).

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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Dysphasia
  • Drug: Methylprednisolone
    Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
  • Drug: Dexamethasone
    Administration of 10mg Dexamethasone IV intraoperatively
  • Active Comparator: Local Depomedrol plus IV dexamethasone
    Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
    Interventions:
    • Drug: Methylprednisolone
    • Drug: Dexamethasone
  • Placebo Comparator: IV dexamethasone
    Standard systemic (IV) dexamethasone only
    Intervention: Drug: Dexamethasone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
102
Same as current
May 30, 2018
July 28, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03308084
15052003
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Kern Singh, Rush University Medical Center
Rush University Medical Center
Not Provided
Principal Investigator: Kern Singh, MD Rush University Medical Center
Rush University Medical Center
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP