Study Stopped
Study was unable to meet patient enrollment goals. PI chose to terminate the study early.
Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery
Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery
1 other identifier
interventional
2
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 11, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
May 8, 2019
CompletedMay 8, 2019
April 1, 2019
1.4 years
July 11, 2013
February 28, 2019
April 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Pain Scores at Rest
72 hours
Opioid Usage
72 hours
Functional Outcomes:The Pediatric Outcomes Data Collection Instrument (PODCI) Score
3 months
Functional Outcomes: Scoliosis Research Society-22r (SRS-22r) Patient Questionnaire
3 months
Functional Outcomes: The Owestry Disability Index(ODI)
3 months
Study Arms (2)
single epidural catheter
ACTIVE COMPARATORdouble epidural catheter
ACTIVE COMPARATORInterventions
epidural catheter with 0.3% ropivacaine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
American Family Children's Hospital
Madison, Wisconsin, 53792, United States
Results Point of Contact
- Title
- Benjamin J. Walker, MD
- Organization
- University of Wisconsin School of Medicine and Public Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2013
First Posted
July 16, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
May 8, 2019
Results First Posted
May 8, 2019
Record last verified: 2019-04