Comparison of Low-Dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
Information source: The University of North Carolina, Chapel Hill
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Bupivacaine, Clonidine, Morphine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of North Carolina Official(s) and/or principal investigator(s):
Michael J Stella, MD, Principal Investigator, Affiliation: The University of North Carolina, Chapel Hill
Summary
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.
Clinical Details
Official title: 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.
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 24 hour recording of pain, sedation, narcotic usage, and satisfaction.
Detailed description:
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).
Eligibility
Minimum age: 4 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of North Carolina, Chapel Hill, North Carolina 27599, United States; Recruiting
Barbara Longmire, Phone: 919-843-2698, Email: oct@unc.edu
Robert Valley, MD, Sub-Investigator
Justin Hauser, MD, Sub-Investigator
Victoria Salo-Coombs, RN, Sub-Investigator
Carl Schuler, RN, Sub-Investigator
Additional Information
Starting date: January 2006
Ending date: June 2006
Last updated: February 27, 2006
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