NCT00663715

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Shorter than P25 for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

March 12, 2015

Status Verified

April 1, 2010

Enrollment Period

10 months

First QC Date

April 18, 2008

Last Update Submit

March 11, 2015

Conditions

Keywords

Sciatic NervePeripheral Nerve BlockLower extremity surgeryLocal AnesthesiaUltrasound guided nerve blocks

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • A secondary objective is to describe correlations between any of the measured variables and the patient's mid-thigh circumference or weight.

    10 minutes

Study Arms (1)

1

Pediatric Patients of ages 11-17

Other: Observation of the Sciatic Nerve

Interventions

Ultrasound will be used to determine the location of the Sciatic Nerve using a lateral mid-thigh approach.

Also known as: Sciatic Nerve location, Peripheral Nerve Blocks
1

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17307781BACKGROUND

Study Officials

  • Arjunan Ganesh, MBBS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 12, 2015

Record last verified: 2010-04