Epidural Study of Patients With Chronic Lower Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and depression, functionality and any side effects of the medication.

Detailed Description
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To determine the optimum dose of local anesthetic and the optimum volume of injected solution when used in an epidural steroid injection being given for pain relief to patients with chronic lower back pain, using pain scores as an assessment tool.

Official Title
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Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Bupivacaine
* Drug: Bupivacaine
* Drug: Bupivacaine
* Drug: Depo-Medrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 years old lower back pains > 6 months no lumbar epidural in past 6 months no previous back surgery written informed consent to participate in study Exclusion Criteria: acute lower back pain pregnancy significant psychiatric disease local or systemic infection coagulopathy/anticoagulant therapy bleeding diathesis presently enrolled in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LV/LD 1<br>Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol | Drug: Bupivacaine<br>* Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)<br>* Other names: steroid;Drug: Depo-Medrol<br>* 80mg Depo-Medrol<br>* Other names: methylprednisolone;|
| Experimental: LV/HD 2<br>Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol | Drug: Bupivacaine<br>* Low Volume, High Dose (5cc, 10mg plain Bupivacaine)<br>* Other names: steroid;Drug: Depo-Medrol<br>* 80mg Depo-Medrol<br>* Other names: methylprednisolone;|
| Experimental: HV/LD 3<br>High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol | Drug: Bupivacaine<br>* High Volume, Low Dose (10cc, 5mg plain Bupivacaine)<br>* Other names: steroid;Drug: Depo-Medrol<br>* 80mg Depo-Medrol<br>* Other names: methylprednisolone;|
| Experimental: HV/HD 4<br>High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol | Drug: Bupivacaine<br>* High Volume, High Dose (10cc, 10mg plain Bupivacaine)<br>* Other names: steroid;Drug: Depo-Medrol<br>* 80mg Depo-Medrol<br>* Other names: methylprednisolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief. |  | Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events. |  | Oswestry scores and HADS scores will be calculated at 5 time periods throughout the study period, prior to 1st, 2nd, and 3rd injections and at 3 and 6 month post the three month injection. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural, volume, dose, pain relief, steroid