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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 18, 2008 | ||||||||
| Last Updated Date | September 14, 2009 | ||||||||
| Start Date ICMJE | April 2009 | ||||||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The primary objective is to describe the appearance of the sciatic nerve and its location in relation to adjacent anatomic structures using ultrasound from the lateral mid-thigh position. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00663715 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
A secondary objective is to describe correlations between any of the measured variables and the patient's mid-thigh circumference or weight. [ Time Frame: 10 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ultrasound Description of the Sciatic Nerve | ||||||||
| Official Title ICMJE | Anatomical Description of the Sciatic Nerve Via a Lateral Mid-Thigh Approach Using Ultrasound | ||||||||
| Brief Summary | Sciatic nerve blocks are frequently used for anesthesia or analgesia for surgery of the lower legs. Currently, if ultrasound is used to find the sciatic nerve, the leg must be raised to locate the nerve with the ultrasound probe on the back of the thigh. In pediatric surgery, the patients are anesthetized (asleep) before the block is given. It is difficult for one person to administer the sciatic nerve block using this method. We would like to identify the sciatic nerve using ultrasound on the side of the thigh and its location to the adjacent structures. |
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| Detailed Description | The sciatic nerve block is frequently used for anesthesia or analgesia for surgery of the lower extremities. Ultrasound-guided sciatic nerve blocks performed at the lateral mid-femoral level have been successfully described with subjects in the supine position and the lower limb elevated in order to accommodate the ultrasound probe against the posterior aspect of the thigh. In the pediatric setting in which nerve blocks are commonly performed with the patient anesthetized rather than awake, we find this technique to be unwieldy as a single-operator technique. Using a more ergonomic approach that has not been previously described, we plan to identify and describe the sciatic nerve with the ultrasound positioned against the lateral aspect of the thigh. We hope to describe the appearance of the sciatic nerve and its location in relation to adjacent anatomic structures using this modified approach. This a prospective cross-sectional study of 40 pediatric subjects 11-17 years of age. Three ultrasound images of the sciatic nerve will be obtained via the lateral mid-thigh approach in 40 pediatric patients scheduled to undergo sciatic nerve block - the first image prior to placement of the block, the second after the nerve is located by the stimulating needle and the third after the injection of local anesthetic. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Case-Only, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Other: Observation of the Sciatic Nerve | ||||||||
| Study Arms / Comparison Groups | Pediatric Patients of ages 11-17 | ||||||||
| Publications * | Karmakar MK, Kwok WH, Ho AM, Tsang K, Chui PT, Gin T. Ultrasound-guided sciatic nerve block: description of a new approach at the subgluteal space. Br J Anaesth. 2007 Mar;98(3):390-5. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | June 2010 | ||||||||
| Estimated Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: None |
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| Gender | Both | ||||||||
| Ages | 11 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00663715 | ||||||||
| Responsible Party | Arjunan Ganesh, MBBS, The Children's Hospital Of Philadelphia | ||||||||
| Study ID Numbers ICMJE | 2008-02-5808 | ||||||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||||||
| Collaborators ICMJE | Children's Anesthesiology Associates, Ltd. | ||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||||||
| Verification Date | September 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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