Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

Not Applicable

Terminated

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Drug: epidural catheter

• Registration Number: NCT01900626
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-16
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2019-02-28
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-16
• Last Update Submitted: 2019-04-16
• Results First Posted: 2019-05-08
• Last Update Posted: 2019-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single epidural catheter	epidural catheter	-
double epidural catheter	epidural catheter	-

Primary Outcome Measures

Name	Time	Method
Pain Scores With Activity	72 hours	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

Secondary Outcome Measures

Name	Time	Method
Pain Scores at Rest	72 hours	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
Opioid Usage	72 hours	Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome
Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire	3 months	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
Functional Outcomes: The Owestry Disability Index(ODI)	3 months	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.
Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score	3 months	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

Trial Locations

Locations (1)

American Family Children's Hospital; 🇺🇸 Madison, Wisconsin, United States