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: April 15, 2016

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2006

Last Updated Date

April 15, 2016

Start Date ^ICMJE

January 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00287326 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Bupivacaine, Clonidine, Morphine

Study Arms

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

4 Years to 16 Years (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00287326

Other Study ID Numbers ^ICMJE

05-Anes-231

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of North Carolina, Chapel Hill

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael J Stella, MD

University of North Carolina, Chapel Hill

PRS Account

University of North Carolina, Chapel Hill

Verification Date

June 2009

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

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