Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

N/ATerminatedNCT01900626

University of Wisconsin, Madison2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adolescent Idiopathic Scoliosis

Interventions

epidural catheterDRUG

epidural catheter with 0.3% ropivacaine

Eligibility

Sex: ALLMin age: 11 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients undergoing surgery via a posterior approach for AIS 2. Children ages 11-18 3. ASA physical status 1-2 4. 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) 5. Planned correction of at least 8 vertebral levels Exclusion Criteria: 1. Patient refusal to participate 2. Patients on chronic narcotic medication 3. Allergy to standard of care drugs used in the study (Omnipaque, ropivacaine, hydromorphone, oxycodone, acetaminophen, gabapentin, ondansetron, nalbuphine or diphenhydramine, diazepam) 4. Coagulopathy 5. Pre-existing neurological deficit 6. Inability to use a Numerical Rating Scale (NRS: 0-10 patient self-reported score) for pain assessment

Locations (1)

American Family Children's Hospital

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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

Time frame: 72 hours

Secondary Outcomes

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

Time frame: 72 hours

Opioid Usage

Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 3 months

Data from ClinicalTrials.gov

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