Clinical trial NCT03543033: Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes
Official title: Randomized Control Trial Comparing Pain and Functional Outcome Following Single Level Lumbar Nerve Decompression Surgery With or Without Preoperative Corticosteroid Epidural Injection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lumbar Radiculopathy
Keywords: lumbar radiculopathy
corticosteroid epidural injection
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial with randomization ratio 1:1
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Use - conversion to oral morphine equivalents using standard table
timeFrame: Primary endpoint is 3 Months
Secondary outcomes:
measure: Disability - Oswestry Disability Index (ODI)
timeFrame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
measure: Pain - Visual Analog Scale (VAS)
timeFrame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
measure: Quality of Life - EuroQol-5D
timeFrame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op
Other outcomes:
measure: Cost Analysis - Health Resource Diary
timeFrame: 1 week post-op, 1 month post-op, 3 months post-op
Locations:
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
Study officials:
affiliation: Lahey Clinic
name: Erica J Bial, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Clinic
name: Robert G Whitmore, M.D.
role: PRINCIPAL_INVESTIGATOR
References: