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

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00287326
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Bupivacaine, Clonidine, Morphine	Phase 3

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2006
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. 24 hour recording of pain, sedation, narcotic usage, and satisfaction. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Michael J Stella, MD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00287326
• Other Study ID Numbers: 05-Anes-231
• First Posted: Feb 6, 2006
• Last Update Posted: Apr 19, 2016
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Epidural; Bupivacaine; Clonidine
• Additional relevant MeSH terms: Clonidine; Morphine; Bupivacaine

Study Results

No Results Posted as of Apr 19, 2016