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| Name | Class |
|---|---|
| St. Joseph's Healthcare Hamilton | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LV/LD 1 | Experimental | Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol |
|
| LV/HD 2 | Experimental | Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol |
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| HV/LD 3 | Experimental | High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol |
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| HV/HD 4 | Experimental | High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian Mulcaster, MD | Hamilton Health Sciences Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | Canada |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D013256 | Steroids |
| D000077555 | Methylprednisolone Acetate |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | Low Volume, High Dose (5cc, 10mg plain Bupivacaine) |
|
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| Bupivacaine | Drug | High Volume, Low Dose (10cc, 5mg plain Bupivacaine) |
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| Bupivacaine | Drug | High Volume, High Dose (10cc, 10mg plain Bupivacaine) |
|
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| Depo-Medrol | Drug | 80mg Depo-Medrol |
|
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| D000588 |
| Amines |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |