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NCT Number: NCT03308084

Use of Local Intraoperative Steroid in MIS TLIF

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).

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Key information

Conditions

Dysphasia Aphasia Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure

Dexamethasone

Drug

Administration of 10mg Dexamethasone IV intraoperatively

Primary outcomes

  1. Postoperative Pain

    Time frame: 2 years postoperative

    Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2017
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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