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Use of Local Intraoperative Steroid in MIS TLIF

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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

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Dysphasia Drug: Methylprednisolone Drug: Dexamethasone Phase 3

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  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion
Actual Study Start Date : November 13, 2015
Actual Primary Completion Date : July 28, 2017
Estimated Study Completion Date : May 30, 2018


Arm Intervention/treatment
Active Comparator: Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
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
Placebo Comparator: IV dexamethasone
Standard systemic (IV) dexamethasone only
Drug: Dexamethasone
Administration of 10mg Dexamethasone IV intraoperatively



Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 2 years postoperative ]
    Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed


Secondary Outcome Measures :
  1. Physical Functioning [ Time Frame: 2 years postoperative ]
    Patient-Reported Outcomes Measurement Information System score as compared to preoperative value

  2. Disability [ Time Frame: 2 years postoperative ]
    Oswestry Disability Index score as compared to preoperative score

  3. General health status [ Time Frame: 2 years postoperative ]
    Short Form-12 Survey scores as compared to preoperative value

  4. 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

  5. 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.

  6. Intra-operative adverse events [ Time Frame: day of surgery ]
    Blood loss, length of surgery, procedural details, complications

  7. 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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308084


Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Kern Singh, MD Rush University Medical Center

Publications:
Responsible Party: Kern Singh, Professor, Department of Orthopaedic Surgery, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03308084     History of Changes
Other Study ID Numbers: 15052003
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kern Singh, Rush University Medical Center:
transforaminal lumbar interbody fusion, methylprednisolone

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Prednisolone acetate
Methylprednisolone acetate
Dexamethasone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors