Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

April 16, 2019 updated by: University of Wisconsin, Madison

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • American Family Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: single epidural catheter
Drug: epidural catheter
epidural catheter with 0.3% ropivacaine
Active Comparator: double epidural catheter
Drug: epidural catheter
epidural catheter with 0.3% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores With Activity
Time Frame: 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
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores at Rest
Time Frame: 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
72 hours
Opioid Usage
Time Frame: 72 hours
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
Time Frame: 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
3 months
Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire
Time Frame: 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
3 months
Functional Outcomes: The Owestry Disability Index(ODI)
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 15, 2013

First Posted (Estimate)

July 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-0109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adolescent Idiopathic Scoliosis

Clinical Trials on epidural catheter

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe