Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

Conditions
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Scoliosis

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diagnosis of Congenital Scoliosis Clinical Diagnosis of Idiopathic Scoliosis Anticipated Spinal Fusion Surgery Exclusion Criteria: Less than 8 years of age

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>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. | Drug: Bupivacaine<br>* Bupivacaine 0.25 - 0.5% @ 4ml/hr for 72 hours<br>* Other names: Marcaine;|
| Placebo Comparator: Arm 2<br>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. | Drug: Normal Saline<br>* Normal Saline, 4ml/hour for 72 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain score |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Therapy Progress |  | Post-op day 1, 2, 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital Scoliosis, Idiopathic Scoliosis, Spinal Fusion, Post-Operative Pain Management, Infusion Catheter