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Post-operative pain following lumbar spine fusion is frequently difficult to manage and can lead to increased doses of opiate pain medications to control pain. In this study, the use of subcutaneous local anesthesia will be studied to determine its efficacy at reducing post-operative pain following spinal fusion surgery.
For patients randomized to the experimental or to the placebo groups, two subcutaneous catheters will be tunneled under the skin with large hollow-bore needles along the entire length of the incision on either side prior to closure. These catheters will deliver study drug (0.25% Marcaine) directly into the incision. They will be affixed to the skin with steri-strips. The catheters will then be attached to a drug delivery pump at 2mL/hour and will be removed prior to discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Normal treatment paradigm (no anesthetic pump) with pain medications, only. | |
| Marciano Group | Active Comparator | Subcutaneous pain control with OnQ pump (0.25% Marcaine at 2ml/hr) and pain medications. |
|
| Placebo Group | Placebo Comparator | OnQ pump with placebo (normal saline at 2ml/hr) and pain medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.25% Marcaine at 2ml/hr and pain medications | Drug | Subcutaneous pain control with OnQ Subcutaneous Drug pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain control | A daily Visual Analog Score Pain scale (1-10) for pain severity, (1 least pain, 10 most pain) will be assessed and recorded daily by a blinded assessor. | From post operative day 1 until patient discharge or 30 days, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge | Number of hospital days from time when patient surgery is completed to discharge will be assessed | from the day of hospital admission to the day of hospital discharge or 45 days, whichever comes first. |
| Total Milligrams of IV pain medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15220788 | Background | Gottschalk A, Freitag M, Tank S, Burmeister MA, Kreil S, Kothe R, Hansen-Algenstedt N, Weisner L, Staude HJ, Standl T. Quality of postoperative pain using an intraoperatively placed epidural catheter after major lumbar spinal surgery. Anesthesiology. 2004 Jul;101(1):175-80. doi: 10.1097/00000542-200407000-00027. | |
| 11020770 | Background |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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This trial is a comparative trial investigating outcomes in 3 parallel groups. The control group will receive standard of care pain control following surgery, the Marcaine group will receive infusion of FDA approved Marcaine around the operative site following surgery through an FDA approved surgical device. The Placebo group will have the drug delivery device implanted with delivery of saline.
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| Placement of OnQ Drug pump | Device | Subcutaneous placement of OnQ drug pump with normal saline infusion |
|
Total milligrams of IV pain medications will be assessed |
| from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first |
| Total Doses of IV pain medication | Number of doses of IV pain medications will be assessed | from the first post-operative dose of IV pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first |
| Total Milligrams of oral pain medication | Total milligrams of oral pain medications will be assessed | from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first |
| Total Doses of oral pain medication | Total doses of oral pain medications will be assessed | from the first post-operative dose of oral pain medication until the last dose prior to discharge from the hospital or 45 days, whichever comes first |
| Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available. |
| 21102963 | Background | Manchikanti L, Singh V, Cash KA, Pampati V, Datta S. Management of pain of post lumbar surgery syndrome: one-year results of a randomized, double-blind, active controlled trial of fluoroscopic caudal epidural injections. Pain Physician. 2010 Nov-Dec;13(6):509-21. |
| 24436846 | Background | Reynolds RA, Legakis JE, Tweedie J, Chung Y, Ren EJ, Bevier PA, Thomas RL, Thomas ST. Postoperative pain management after spinal fusion surgery: an analysis of the efficacy of continuous infusion of local anesthetics. Global Spine J. 2013 Mar;3(1):7-14. doi: 10.1055/s-0033-1337119. Epub 2013 Mar 2. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |