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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.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01900626
First Posted: July 16, 2013
Last Update Posted: October 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900626


Locations
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
ClinicalTrials.gov Identifier: NCT01900626     History of Changes
Other Study ID Numbers: Epidural for Scoliosis
First Submitted: July 11, 2013
First Posted: July 16, 2013
Last Update Posted: October 2, 2015
Last Verified: December 2014

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