Ultrasound Description of the Sciatic Nerve | NCT00663715

Studies
Ultrasound Description of the Sciatic Nerve

NCT00663715

Sponsor

Children's Hospital of Philadelphia

Status

Withdrawn

Last Update Posted

Mar 12, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Sciatic Nerve AH
Peripheral Nerves US

Interventions

Observation of the Sciatic Nerve

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No subjects were enrolled. Sciatic blocks infrequently used for pain control.

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Feb 2010Estimated

Completion Date

Feb 2010Estimated

First Submitted Date

Apr 18, 2008

First Submission Date that Met QC Criteria

Apr 18, 2008

First Posted Date

Apr 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2015

Last Update Posted Date

Mar 12, 2015Estimated

Name	Class
Children's Anesthesiology Associates, Ltd.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Pediatric Patients of ages 11-17	Other: Observation of the Sciatic Nerve

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation of the Sciatic Nerve	Other	Ultrasound will be used to determine the location of the Sciatic Nerve using a lateral mid-thigh approach.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		10 minutes

Secondary Outcomes

Measure	Description	Time Frame
A secondary objective is to describe correlations between any of the measured variables and the patient's mid-thigh circumference or weight.		10 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females 11 to 17 years old.
Patients undergoing lower extremity surgery who are scheduled to have a sciatic nerve block as part of the anesthetic.
Parental/guardian permission (verbal consent) and child assent. Note: if you record ANY PHI, you will need to obtain written consent since HIPAA requires written authorization for use of PHI.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Pediatric patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arjunan Ganesh, MBBS	Children's Hospital of Philadelphia	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17307781	Background	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. doi: 10.1093/bja/ael364.