Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy (Intra Op)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04182997
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Don Moore, University of Missouri-Columbia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Lumbar Disc Herniation Drug: Dexamethasone Drug: saline 0.9% Phase 4

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: the patient and any treating physicians will be blinded to which arm the patient was assigned. This will be accomplished by the research coordinator determining the randomization status and passing this information along to a surgical nurse. The nurse will the procure either the placebo or treatment drug and give it to the treating physician in an non-descript container so that the appearance will not give away the type of liquid being used.
Primary Purpose: Treatment
Official Title: Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy for Herniated Lumbar Discs Is There a Role? - A Randomized Control Trial
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo Group
Patients in this group will be given the placebo (sterile saline).
 Drug: saline 0.9%
Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
Other Name: sterile saline
Active Comparator: Dexamethasone Group
Patients in this group will be given the study drug (dexamethasone).
 Drug: Dexamethasone
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Post Operative Pain Scores [ Time Frame: Until final follow up (up to 8 weeks) ]
    Comparing post operative pain scores between treatment and placebo group. Using VAS pain score with scale 0 to 10 with 0 being no pain and 10 being the worst pain of your life.


Secondary Outcome Measures :
  1. Length of stay [ Time Frame: Until final follow up (up to 8 weeks) ]
    Determining how long patient is in hospital

  2. Post Operative Opioid Usage [ Time Frame: Until final follow up (up to 8 weeks) ]
    comparing opioid usage post operatively

  3. Post Operative Complications [ Time Frame: Until final follow up (up to 8 weeks) ]
    comparing rate of post-op infections


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 beta hCG testing will be performed prior to enrollment
  • Diagnosis of or symptoms concerning for cauda equina syndrome
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04182997


Contacts
Layout table for location contacts
Contact: Stacee Clawson, BSN, RN (573) 884-9017 clawsons@health.missouri.edu

Locations
Layout table for location information
United States, Missouri
University of Missouri Health System Recruiting
Columbia, Missouri, United States, 65212
Contact: Susan Kady, BSN, RN    573-884-1925    kadysj@missouri.edu   
Principal Investigator: Don Moore, MD         
Sub-Investigator: Theodore Choma, MD         
Sub-Investigator: Muhammad Mirza, MD         
Sponsors and Collaborators
University of Missouri-Columbia
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Layout table for additonal information
Responsible Party: Don Moore, Assistant Professor, Orthopedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04182997     History of Changes
Other Study ID Numbers: 2014147
First Posted: December 2, 2019    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Pathological Conditions, Anatomical
Dexamethasone
Dexamethasone acetate
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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action