Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 75
Updated:2/6/2019
Start Date:September 10, 2018
End Date:September 20, 2019
Contact:Jenna Whooley, B.S
Email:jenna.whooley@lahey.org
Phone:781-744-1190

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Randomized Control Trial Comparing Pain and Functional Outcome Following Single Level Lumbar Nerve Decompression Surgery With or Without Preoperative Corticosteroid Epidural Injection

This randomized control trial will compare opioid use, pain, and functional outcomes
following decompression surgery for single-level lumbar radiculopathy in patients who undergo
placement of corticosteroid epidural injection within 2 weeks prior to surgery compared to
those who do not. The hypothesis of this study is that patients who receive the preoperative
corticosteroid injection will have less reduced postoperative opioid use, as well as earlier
mobilization, reduced length of stay, and faster return to work compared to control patients
who do not receive the injection.

This is a randomized control study that will be completed within the Department of
Neurosurgery at Lahey Hospital & Medical Center. Patients will undergo their recommended
surgery to treat single-level lumbar radiculopathy. Patients who are randomized to and
consent to receiving a preoperative corticosteroid injection will report to clinic within 2
weeks prior to date of surgery to receive a corticosteroid injection. These subjects will
first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5
ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used
to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of
sterile PF saline. To assure the injection is epidural, we will be using loss of resistance
technique under fluoroscopy and epidural placement will be confirmed with the live-image
instillation in the AP and lateral positions of dye, with pattern confirming epidermal needle
placement.

All patients will complete health outcome questionnaires (VAS, EQ-5D, ODI) at baseline
(treatment cohort: prior to injection, control cohort: prior to spine surgery), 1 week
post-op, 1 month post-op, and 3 months post-op. Patients will be instructed to bring all
condition-related pain medication containers to each follow-up for research measuring
purposes. Research personnel will record number of pills remaining in container, number of
opioid prescription refills, and respective dates. Opioid usage for each subject will be
tracked and converted to mg oral morphine equivalents using a standard table. Research
personnel will capture additional clinic information such as length of stay, length of time
before ambulation, and occurrence of any complications (i.e. DVT, infection). Opioid use,
muscle relaxants, and other pain medication use will be followed for 3 months. At baseline
and at each post-op follow up, patients will be asked to define their use of illicit drugs
over the past 6 months (heroin, cocaine, marijuana, methamphetamine, other). Return to work
date and work status will be captured out to 3 months. Patients will submit a health-cost
diary at 1 week, 1 month, and 3 months, and this data will be combined with hospital-based
cost information to generate a cost analysis. This diary will capture costs such as
medication costs, copayments, travel, etc. Additionally, all patient surgery cancelations as
well as reason for cancelation will be recorded. No additional medical testing will be
required by the patient.

Inclusion Criteria:

1. Patients 30-75 years of age

2. Patients diagnosed with diagnoses with single level unilateral lumbar radiculopathy

3. Patients diagnosed with spinal stenosis or disc herniation

4. Patients who have a history of > 6 weeks of at least 1 conservative treatment

5. ASA < III

Exclusion Criteria:

1. Patients who have undergone previous lumbar spinal surgery at index level

2. Patients diagnosed with spondylolisthesis at index level

3. Patients currently taking anti-coagulant therapy

4. Active treatment of major psychiatric condition such as major depression and/or
anxiety disorder.

5. Patients currently seeking or receiving workers compensation

6. Patients who have undergone previous corticosteroid injection at index level

7. Morbid obesity defined as BMI > 40

8. Patients with history of chronic opioid use

9. Patients with a contrast dye allergy

10. Extruded disc fragment
We found this trial at
1
site
Burlington, Massachusetts 01805
?
mi
from
Burlington, MA
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