Preoperative Corticosteroid Epidural Injection and Lumbar Decompression Surgery Outcomes
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03543033|
Recruitment Status : Withdrawn (The study was closed by the investigators due to lack of study population to enroll.)
First Posted : June 1, 2018
Last Update Posted : June 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Radiculopathy||Drug: Corticosteroid injection||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Control Trial with randomization ratio 1:1|
|Official Title:||Randomized Control Trial Comparing Pain and Functional Outcome Following Single Level Lumbar Nerve Decompression Surgery With or Without Preoperative Corticosteroid Epidural Injection|
|Actual Study Start Date :||September 10, 2018|
|Actual Primary Completion Date :||May 1, 2020|
|Actual Study Completion Date :||May 1, 2020|
Patients will receive a corticosteroid epidural injection within 2 weeks of their scheduled lumbar surgery
Drug: 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
No Intervention: Control
Patients will not receive a corticosteroid injection within 2 weeks of their scheduled lumbar surgery.
- Opioid Use - conversion to oral morphine equivalents using standard table [ Time Frame: Primary endpoint is 3 Months ]Following spine surgery, # of prescription opioid pills used will be recorded and converted to oral morphine equivalents using a standard table. Information collected will include # of pills taken, # of prescription refills, and respective dates.
- Disability - Oswestry Disability Index (ODI) [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]Oswestry Disability Index (ODI) will be used to measure disability associated with their spinal condition. The ODI contains 10 questions; each with 6 choices and each answer choice ranges from 0 to 5 points. The minimum score is 0 and maximum score is 50; the higher the score, the greater the disability indicated. Each question is 5 points each and is summed then divided by total possible point. Scores from each cohort will be compared.
- Pain - Visual Analog Scale (VAS) [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]VAS will be used to measure pain and discomfort. The scale is a horizontal line numbered 0 through 10 with "0" indicating no pain, "5" indicating moderate pain, and 10 indicating worst pain. Patients will be instructed to mark an "X" on the number corresponding to their level of back pain over the past week. They will also be asked to indicate their leg pain on a similar, but separate scale. Scores from each cohort will be compared.
- Quality of Life - EuroQol-5D [ Time Frame: Baseline, 1 week post-op, 1 month post-op, and 3 months post-op ]EuroQol-5D (EQ-5D) will be used to measure quality of life. The EQ-5D includes 5 multiple-choice questions with 3 choices each; each choice corresponding to a value of 1,2,or 3. Each value is entered into an algorithm that computes a score. The score can range from "1" = high quality of life" and "0" = poor quality of life. Scores will be compared between both cohorts.
- Cost Analysis - Health Resource Diary [ Time Frame: 1 week post-op, 1 month post-op, 3 months post-op ]A self-administered health resource diary will be completed by the patient. Information on co payments, travel costs, medical devices, and medical tests will be collected. Along with their estimated costs or receipts.
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): NCT03543033
|United States, Massachusetts|
|Lahey Hospital & Medical Center|
|Burlington, Massachusetts, United States, 01803|
|Principal Investigator:||Erica J Bial, M.D., M.S.||Lahey Clinic|
|Principal Investigator:||Robert G Whitmore, M.D.||Lahey Clinic|