Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

Study Overview
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Brief Summary
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This is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.

Official Title
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Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Drug: epidural catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing surgery via a posterior approach for AIS Children ages 11-18 ASA physical status 1-2 Informed consent by legal guardian and assent by patient (for minors 11-17 years of age) or informed consent by subject (for patients 18 years of age) Planned correction of at least 8 vertebral levels Exclusion Criteria: Patient refusal to participate Patients on chronic narcotic medication Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam) Coagulopathy Pre-existing neurological deficit Inability to use a Numerical Rating Scale (NRS: 0-10 patient self-reported score) for pain assessment

Ages Eligible for Study
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Minimum Age: 11 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single epidural catheter<br> | Drug: epidural catheter<br>* epidural catheter with 0.3% ropivacaine<br>|
| Active Comparator: double epidural catheter<br> | Drug: epidural catheter<br>* epidural catheter with 0.3% ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores With Activity | The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores at Rest | The pain scores will be examined using the Numeric Rating Scale (NRS). NRS score ranges from 0-10. Higher score represents more pain/worse outcome | 72 hours | 
| Opioid Usage | Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome | 72 hours | 
| Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score | Functional outcome will be measured by the Pediatric Outcomes Data Collection Instrument (PODCI). Scores range from 0-100, lower score represents higher degree of disability | 3 months | 
| Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire | Functional outcome will be measured by the Scoliosis Research Society-22r (SRS-22r). Scores range from 0-110, higher scores represent less disability/better outcome | 3 months | 
| Functional Outcomes: The Owestry Disability Index(ODI) | Functional outcome will be measured by the Owestry Disability Index (ODI). ODI represents following disability levels: 0% -20%: Minimal disability, 21%-40%: Moderate Disability, 41%-60%: Severe Disability, 61%-80%: Crippling back pain, 81%-100%: These patients are either bed-bound or have an exaggeration of their symptoms. | 3 months |