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Use of Local Intraoperative Steroid in MIS TLIF

Primary Purpose

Dysphasia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Methylprednisolone
Dexamethasone
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysphasia focused on measuring transforaminal lumbar interbody fusion, methylprednisolone

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Local Depomedrol plus IV dexamethasone

    IV dexamethasone

    Arm Description

    Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone

    Standard systemic (IV) dexamethasone only

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 5, 2017
    Last Updated
    November 18, 2020
    Sponsor
    Rush University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03308084
    Brief Title
    Use of Local Intraoperative Steroid in MIS TLIF
    Official Title
    Effects of Intraoperative Local Steroid Utilization in a Single-Level Minimally Invasive Transforaminal Lumbar Interbody Fusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 13, 2015 (Actual)
    Primary Completion Date
    May 3, 2019 (Actual)
    Study Completion Date
    May 3, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rush University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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: 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphasia
    Keywords
    transforaminal lumbar interbody fusion, methylprednisolone

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Local Depomedrol plus IV dexamethasone
    Arm Type
    Active Comparator
    Arm Description
    Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
    Arm Title
    IV dexamethasone
    Arm Type
    Placebo Comparator
    Arm Description
    Standard systemic (IV) dexamethasone only
    Intervention Type
    Drug
    Intervention Name(s)
    Methylprednisolone
    Intervention Description
    Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    Administration of 10mg Dexamethasone IV intraoperatively
    Primary Outcome Measure Information:
    Title
    Postoperative Pain
    Description
    Change in Visual Analogue Scale Back and Leg score from preoperative value will be assessed
    Time Frame
    2 years postoperative
    Secondary Outcome Measure Information:
    Title
    Physical Functioning
    Description
    Patient-Reported Outcomes Measurement Information System score as compared to preoperative value
    Time Frame
    2 years postoperative
    Title
    Disability
    Description
    Oswestry Disability Index score as compared to preoperative score
    Time Frame
    2 years postoperative
    Title
    General health status
    Description
    Short Form-12 Survey scores as compared to preoperative value
    Time Frame
    2 years postoperative
    Title
    Narcotic Consumption
    Description
    The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents
    Time Frame
    1 week postoperative
    Title
    Length of Stay
    Description
    The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.
    Time Frame
    1 week postoperative
    Title
    Intra-operative adverse events
    Description
    Blood loss, length of surgery, procedural details, complications
    Time Frame
    day of surgery
    Title
    Post-operative adverse events
    Description
    Post-operative nausea and vomiting, Gastro-esophageal reflux, Ileus, Venous thromboembolic events, Respiratory depression/airway compromise, Renal insufficiency, Wound Complications, Admission to the ICU
    Time Frame
    1 week postoperative

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kern Singh, MD
    Organizational Affiliation
    Rush University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19023571
    Citation
    Schizas C, Tzinieris N, Tsiridis E, Kosmopoulos V. Minimally invasive versus open transforaminal lumbar interbody fusion: evaluating initial experience. Int Orthop. 2009 Dec;33(6):1683-8. doi: 10.1007/s00264-008-0687-8. Epub 2008 Nov 21.
    Results Reference
    background
    PubMed Identifier
    21417699
    Citation
    McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.
    Results Reference
    background
    PubMed Identifier
    21121754
    Citation
    Ranguis SC, Li D, Webster AC. Perioperative epidural steroids for lumbar spine surgery in degenerative spinal disease. A review. J Neurosurg Spine. 2010 Dec;13(6):745-57. doi: 10.3171/2010.6.SPINE09796.
    Results Reference
    background
    PubMed Identifier
    24885519
    Citation
    Jamjoom BA, Jamjoom AB. Efficacy of intraoperative epidural steroids in lumbar discectomy: a systematic review. BMC Musculoskelet Disord. 2014 May 5;15:146. doi: 10.1186/1471-2474-15-146.
    Results Reference
    background
    PubMed Identifier
    12177541
    Citation
    Debi R, Halperin N, Mirovsky Y. Local application of steroids following lumbar discectomy. J Spinal Disord Tech. 2002 Aug;15(4):273-6. doi: 10.1097/00024720-200208000-00002.
    Results Reference
    background
    PubMed Identifier
    30497132
    Citation
    Haws BE, Khechen B, Patel DV, Bawa MS, Ahn J, Bohl DD, Mayo BC, Massel DH, Guntin JA, Cardinal KL, Singh K. Impact of local steroid application in a minimally invasive transforaminal lumbar interbody fusion: results of a prospective, randomized, single-blind trial. J Neurosurg Spine. 2018 Nov 9;30(2):222-227. doi: 10.3171/2018.7.SPINE18584.
    Results Reference
    derived

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    Use of Local Intraoperative Steroid in MIS TLIF

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