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The purpose of this study is to evaluate the effects of continuous local anesthetic delivery on the immediate post-op recovery of patients undergoing spinal fusion surgery for congenital or idiopathic scoliosis.
Constant local analgesic infusion is a relatively new modality that provides a constant supply of medication without the need for repeat injections. This method has shown encouraging results with respect to pain levels, narcotic use, faster rehabilitation and shorter hospital stay in patients undergoing laparotomies, iliac crest bone graft harvest, and sternotomies. In addition, there have not been any reported complications when used in these scenarios.
We hope to confirm better pain control, less narcotic use (i.e. PCA), fewer narcotic side effects, better response to physical therapy and earlier discharge. Which may be generalized to the spinal surgery patient population as less pain and suffering and a better overall hospital course
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Subjects in arm 1 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse 0.25 - 0.5% (according to patient's weight) Bupivacaine at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management. |
|
| Arm 2 | Placebo Comparator | Subjects in arm 2 will intraoperatively have a continuous infusion catheter placed in the paraspinal musculature of the posterior spinal wound. Post-operatively, the catheter will infuse normal saline at a rate of 4ml/hr for 72 hours. This is in addition to the standardized PCA pain management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| VAS pain score | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Therapy Progress | Post-op day 1, 2, 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norman Otsuka, MD | Shriners Hospitals for Children - Los Angeles | Study Director |
| Anthony Scaduto, MD | Shriners Hospitals for Children - Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children - Los Angeles | Los Angeles | California | 90020 | United States |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline | Drug | Normal Saline, 4ml/hour for 72 hours. |
|
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |