Subjective Intraoperative Use of Epidural Steroid Administration Following Discectomy (Intra Op)
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|ClinicalTrials.gov Identifier: NCT04182997|
Recruitment Status : Recruiting
First Posted : December 2, 2019
Last Update Posted : December 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Disc Herniation||Drug: Dexamethasone Drug: saline 0.9%||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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.|
|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|
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).
Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
- 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.
- Length of stay [ Time Frame: Until final follow up (up to 8 weeks) ]Determining how long patient is in hospital
- Post Operative Opioid Usage [ Time Frame: Until final follow up (up to 8 weeks) ]comparing opioid usage post operatively
- Post Operative Complications [ Time Frame: Until final follow up (up to 8 weeks) ]comparing rate of post-op infections
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
|Contact: Stacee Clawson, BSN, RN||(573) firstname.lastname@example.org|
|United States, Missouri|
|University of Missouri Health System||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact: Susan Kady, BSN, RN 573-884-1925 email@example.com|
|Principal Investigator: Don Moore, MD|
|Sub-Investigator: Theodore Choma, MD|
|Sub-Investigator: Muhammad Mirza, MD|