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Comparison of Low-Dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone

This study has been terminated.
(terminated by PI)
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00287326
First received: February 3, 2006
Last updated: June 23, 2009
Last verified: June 2009
History of Changes

February 3, 2006
June 23, 2009
January 2006
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24 hour recording of pain, sedation, narcotic usage, and satisfaction.
Same as current
Complete list of historical versions of study NCT00287326 on ClinicalTrials.gov Archive Site
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Comparison of Low-Dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
Comparison of Epidural Bupivacaine-Clonidine With Intravenous Morphine Versus Intravenous Morphine Alone for Post-Operative Pain Relief in Pediatric Patients Undergoing Lower Extremity or Pelvic Osteotomy.

The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage, and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy.

Post-operative pain in patients undergoing osteotomy can be severe. Current methods of treatment involve parenteral narcotics and regional anesthesia. Several studies have looked at the efficacy of regional anesthesia with various combinations of local anesthetic and additives in different populations. However, to our knowledge there have been none that directly compare bupivacaine/clonidine epidural with supplemental narcotics to parenteral narcotics alone. Many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia (1,2,3). Parenteral narcotic alone is associated with the possibility of significant side effects, overdose, and inadequate analgesia. Epidural analgesia has been shown to reduce postoperative pain scores more than parenteral narcotics (4). We believe that this study is important since the protocol allows additional parenteral narcotic in the epidural group if needed, and also allows for narcotic dosing prior to discontinuation of the epidural to compensate for rebound pain. Further, the prolongation of pain control shown with epidural clonidine may be beneficial during the transition (5,6).
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pain
Drug: Bupivacaine, Clonidine, Morphine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
June 2006
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Inclusion Criteria:

  • Age 4-16
  • English speaking
  • Elective lower extremity osteotomy
  • Expected length of stay greater than 24 hours

Exclusion Criteria:

  • History of previous spine surgery
  • Current infection overlying catheter insertion site
  • Coagulopathy
Both
4 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00287326
05-Anes-231
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University of North Carolina, Chapel Hill
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Principal Investigator: Michael J Stella, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP