Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy (Intra-Op)
Primary Purpose
Lumbar Disc Herniation
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
saline 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a clinical assessment indicative of a lumbar disc herniation
- Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
- Radiculopathy present - positive tension signs or sensory/motor neurologic deficits present
- Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation
Exclusion Criteria:
- Concomitant spinal stenosis, segmental instability, or spondylolisthesis
- Previous surgery at the affected level or recurrent herniation
- Underlying disease that may affect response to steroids - immunocompromise, use of chronic steroids or immunosuppression
- Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
- Diagnosis of or symptoms concerning for cauda equina syndrome
Sites / Locations
- Casey A FogartyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo Group
Dexamethasone Group
Arm Description
Patients in this group will be given the placebo (sterile saline).
Patients in this group will be given the study drug (dexamethasone).
Outcomes
Primary Outcome Measures
Post Operative Pain Scores
Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.
Post Operative Oswestry Disability Index
Comparing post operative disability scores between treatment and placebo group. Using Oswestry Disability Index (ODI) to measure a patient's permanent functional disability and low back functional outcome tools.
Secondary Outcome Measures
Length of stay
Determining how long patient is in hospital
Post Operative Opioid Usage
comparing opioid usage post operatively
Post Operative Complications
comparing rate of post-op infections
Full Information
NCT ID
NCT04182997
First Posted
November 25, 2019
Last Updated
March 14, 2023
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT04182997
Brief Title
Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
Acronym
Intra-Op
Official Title
Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2019 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine a grading system for inflammation in lumbar disc herniation and which groups, if any, benefit most from the administration of an intra-operative epidural steroid.
Detailed Description
Intraoperative epidural administration of steroids following discectomy for herniated lumbar disc has been the topic of multiple studies in the literature. The results have been mixed, with the majority of the studies finding some benefit, but outcomes have varied drastically amongst the many studies. The aim of this study is to develop a grading scale for intraoperative assessment of nerve root inflammation to determine if this subjective assessment is an adequate indicator for response to epidural steroids following discectomy. Patients will be allocated randomly preoperatively to the intervention group versus control group. Pictures of the spinal cord and associated nerve root will be captured intraoperatively. These pictures will be scrutinized postoperatively and an inflammation grade will be assigned. The investigators will then identify if nerve roots with a higher-grade of inflammation respond differently to epidural steroid administration when compared to lesser-grades of inflammation. This will be measured with the a variety of outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly assigned to either the treatment group or the placebo group. At the end of surgery patients in the treatment group will have the surgical site lavaged with dexamethasone while patients in the placebo group will have the surgical site lavaged by sterile saline.
Masking
Participant
Masking Description
The patient will be blinded to which arm they were assigned. This will be accomplished by the research coordinator determining the randomization status and passing this information along to a surgical nursing staff. The nurse will the procure either the placebo or treatment drug and give it to the treating physician and announce which treatment drug the patient is receiving.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Patients in this group will be given the placebo (sterile saline).
Arm Title
Dexamethasone Group
Arm Type
Active Comparator
Arm Description
Patients in this group will be given the study drug (dexamethasone).
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
Intervention Type
Drug
Intervention Name(s)
saline 0.9%
Other Intervention Name(s)
sterile saline
Intervention Description
Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
Primary Outcome Measure Information:
Title
Post Operative Pain Scores
Description
Comparing post operative pain scores between treatment and placebo group. Using Visual Analogue Scale (VAS) pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.
Time Frame
Until final follow up (up to 8 weeks)
Title
Post Operative Oswestry Disability Index
Description
Comparing post operative disability scores between treatment and placebo group. Using Oswestry Disability Index (ODI) to measure a patient's permanent functional disability and low back functional outcome tools.
Time Frame
Until final follow up (up to 8 weeks
Secondary Outcome Measure Information:
Title
Length of stay
Description
Determining how long patient is in hospital
Time Frame
Until final follow up (up to 8 weeks)
Title
Post Operative Opioid Usage
Description
comparing opioid usage post operatively
Time Frame
Until final follow up (up to 8 weeks)
Title
Post Operative Complications
Description
comparing rate of post-op infections
Time Frame
Until final follow up (up to 8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presenting to the University of Missouri hospital system - including the University of Missouri Hospital and Missouri Orthopaedic Institute - with a clinical assessment indicative of a lumbar disc herniation
Failed conservative treatment - rest, anti-inflammatory medications, physical therapy
Radiculopathy present - positive tension signs or sensory/motor neurologic deficits present
Recent MRI confirming single-level lumbar disc herniation corresponding to clinical evaluation
Exclusion Criteria:
Concomitant spinal stenosis, segmental instability, or spondylolisthesis
Previous surgery at the affected level or recurrent herniation
Underlying disease that may affect response to steroids - immunocompromise, use of chronic steroids or immunosuppression
Pregnancy - qualitative human chorionic gonadotropin (hCG) testing will be performed prior to enrollment
Diagnosis of or symptoms concerning for cauda equina syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacee Clawson, BSN, RN
Phone
(573) 884-9017
Email
clawsons@health.missouri.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Don Kim Moore, MD
Organizational Affiliation
Missouri Orthopaedic Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Casey A Fogarty
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Casey A Fogarty, BS
Phone
573-882-2328
Email
fogartyca@health.missouri.edu
First Name & Middle Initial & Last Name & Degree
Don Moore, MD
First Name & Middle Initial & Last Name & Degree
Theodore Choma, MD
First Name & Middle Initial & Last Name & Degree
Muhammad Mirza, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26424336
Citation
Akinduro OO, Miller BA, Haussen DC, Pradilla G, Ahmad FU. Complications of intraoperative epidural steroid use in lumbar discectomy: a systematic review and meta-analysis. Neurosurg Focus. 2015 Oct;39(4):E12. doi: 10.3171/2015.7.FOCUS15269.
Results Reference
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24916651
Citation
Aljabi Y, El-Shawarby A, Cawley DT, Aherne T. Effect of epidural methylprednisolone on post-operative pain and length of hospital stay in patients undergoing lumbar microdiscectomy. Surgeon. 2015 Oct;13(5):245-9. doi: 10.1016/j.surge.2014.03.012. Epub 2014 Jun 7.
Results Reference
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PubMed Identifier
29845327
Citation
Arirachakaran A, Siripaiboonkij M, Pairuchvej S, Setrkraising K, Pruttikul P, Piyasakulkaew C, Kongtharvonskul J. Comparative outcomes of epidural steroids versus placebo after lumbar discectomy in lumbar disc herniation: a systematic review and meta-analysis of randomized controlled trials. Eur J Orthop Surg Traumatol. 2018 Dec;28(8):1589-1599. doi: 10.1007/s00590-018-2229-4. Epub 2018 May 29.
Results Reference
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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
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PubMed Identifier
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Citation
Diaz RJ, Myles ST, Hurlbert RJ. Evaluation of epidural analgesic paste components in lumbar decompressive surgery: a randomized double-blind controlled trial. Neurosurgery. 2012 Feb;70(2):414-23; discussion 423-4. doi: 10.1227/NEU.0b013e3182315f05.
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PubMed Identifier
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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.
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Citation
Jirarattanaphochai K, Jung S, Thienthong S, Krisanaprakornkit W, Sumananont C. Peridural methylprednisolone and wound infiltration with bupivacaine for postoperative pain control after posterior lumbar spine surgery: a randomized double-blinded placebo-controlled trial. Spine (Phila Pa 1976). 2007 Mar 15;32(6):609-16; discussion 617. doi: 10.1097/01.brs.0000257541.91728.a1.
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Citation
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Citation
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Citation
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Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy
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