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Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
epidural catheter
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • American Family Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

single epidural catheter

double epidural catheter

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2013
Last Updated
April 16, 2019
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01900626
Brief Title
Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery
Official Title
Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Study was unable to meet patient enrollment goals. PI chose to terminate the study early.
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single epidural catheter
Arm Type
Active Comparator
Arm Title
double epidural catheter
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
epidural catheter
Intervention Description
epidural catheter with 0.3% ropivacaine
Primary Outcome Measure Information:
Title
Pain Scores With Activity
Description
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 Outcome Measure Information:
Title
Pain Scores at Rest
Description
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
Title
Opioid Usage
Description
Hydromorphone usage measured in mcg/kg/day. No min/max. More hydromorphone usage represents worse outcome
Time Frame
72 hours
Title
Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score
Description
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
Title
Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire
Description
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
Title
Functional Outcomes: The Owestry Disability Index(ODI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
American Family Children's Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

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