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Depo-Medrol for Postoperative Pain
Phase 4
Recruiting
Led By Hardeep Singh, M.D.
Research Sponsored by Hardeep Singh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with lumbar disc degeneration
Transpsoas (PTP or LTP) lateral lumbar interbody fusion (LLIF) 1-3 disc levels with posterior instrumentation (Open or MIS) with or without laminectomy, must include L3-4 and/or L4-5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year and 2 years
Awards & highlights
Study Summary
This trial seeks to find out if a medication can help reduce hip weakness, pain, and numbness after spinal surgery.
Who is the study for?
This trial is for adults aged 18-75 with lumbar disc degeneration who are undergoing a specific back surgery (LLIF) involving the L3-4 and/or L4-5 spinal levels. Candidates must not have severe spine curvature, advanced spondylolisthesis, flatback deformity, diabetes requiring insulin, or be chronic oral steroid users. They also can't have allergies to steroids like Depo-Medrol.Check my eligibility
What is being tested?
The study tests whether injecting Depo-Medrol into the psoas muscle after LLIF surgery reduces postoperative hip flexor weakness and thigh pain/numbness. It compares this treatment against Gel-Flow NT to see which is more effective in managing these symptoms.See study design
What are the potential side effects?
Depo-Medrol may cause side effects such as increased blood sugar levels, weakened bones, weight gain, water retention, mood swings or changes in behavior. The severity of side effects varies from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have degeneration in my lumbar disc.
Select...
I had a specific spine surgery involving L3-4 and/or L4-5 levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery.
Secondary outcome measures
Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection.
Quantify the difference in rates of postoperative thigh numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.
Quantify the difference in severity of postoperative hip flexor weakness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection.
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Test group (standard care + study intervention)Experimental Treatment2 Interventions
1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol
Group II: Control group (standard care)Placebo Group1 Intervention
1 cc gel foam powder mixed with thrombin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Depo-Medrol
2005
N/A
~260
Find a Location
Who is running the clinical trial?
Society for Minimally Invasive Spine SurgeryOTHER
1 Previous Clinical Trials
450 Total Patients Enrolled
Hardeep SinghLead Sponsor
Hardeep Singh, M.D.Principal InvestigatorUConn Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fluent in English.My spine condition is more severe than a mild slip.I need surgery on both sides of my spine through the psoas muscle.I have degeneration in my lumbar disc.I have pain in the same side of my hip.You can't have missed any follow-up appointments for the two years after the study.I am scheduled for or have had a revision fusion surgery.You need insulin to manage your diabetes.I have a flatback deformity.My condition involves trauma, tumor, or infection.I have a curve in my spine greater than 10 degrees.I am unable to give consent by myself.You have more than three spinal levels fused together.I am considering or have used alternative spinal devices.You are allergic to depo-medrol or other steroid medications.I had a specific spine surgery involving L3-4 and/or L4-5 levels.I regularly take oral steroids.I am between 18 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Test group (standard care + study intervention)
- Group 2: Control group (standard care)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the combined procedures of Test group (standard care plus study intervention) sanctioned by the FDA?
"Owing to the fact that this is a Phase 4 trial, which has already been approved and is thus safe, our team at Power assigned Test Group (standard care + study intervention) a score of 3."
Answered by AI
Are elderly individuals included in the participant cohort of this experiment?
"The study enrolment criteria requires participants to be in the 18-75 year age bracket. There are 78 research studies for minors and over 478 trials targeting senior citizens."
Answered by AI
Who is eligible to join in this clinical research?
"To be a viable candidate for this research, one must have muscular weakness and fall between 18-75 years old. Thus far, 80 participants have been accepted into the study."
Answered by AI
Is the enrollment process still open for this research undertaking?
"According to information on clinicaltrials.gov, this research program is actively seeking out participants. The first posting for the study was declared on May 12th 2023 and has since been updated as of June 29th 2023."
Answered by AI
How many participants have enrolled in this research endeavor?
"Absolutely. The information posted on clinicaltrials.gov indicates that this medical trial is enrolling patients now, having first been submitted to the platform on May 12th 2023 and most recently edited June 29th 2023. 80 individuals need to be recruited from one location for it to become a success."
Answered by AI
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