Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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.)
Sponsor:
Information provided by (Responsible Party):
Benjamin Walker, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01900626
First received: July 11, 2013
Last updated: December 3, 2014
Last verified: December 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain scores at rest [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • opioid side effects [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • functional outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   11 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900626

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

No publications provided

Responsible Party: Benjamin Walker, Assistant Professor, Dept of Anesthesiology, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01900626     History of Changes
Other Study ID Numbers: Epidural for Scoliosis
Study First Received: July 11, 2013
Last Updated: December 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on March 02, 2015