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Single vs Double Epidural Catheter Analgesia for Scoliosis Surgery

This study has been terminated.
(Study was unable to meet patient enrollment goals. PI chose to terminate the study early.)
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: July 11, 2013
Last updated: October 1, 2015
Last verified: December 2014
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.

Condition Intervention
Adolescent Idiopathic Scoliosis Drug: epidural catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Versus Double Epidural Catheter Technique for Postoperative Analgesia Following Scoliosis Surgery

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • pain scores with activity [ Time Frame: 72 hours ]

Secondary Outcome Measures:
  • pain scores at rest [ Time Frame: 72 hours ]
  • opioid side effects [ Time Frame: 72 hours ]
  • functional outcomes [ Time Frame: 3 months ]

Enrollment: 2
Study Start Date: July 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01900626

United States, Wisconsin
American Family Children's Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT01900626     History of Changes
Other Study ID Numbers: Epidural for Scoliosis
Study First Received: July 11, 2013
Last Updated: October 1, 2015

Additional relevant MeSH terms:
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on September 21, 2017