NCT01049906

Brief Summary

Hypothesis: When performed under ultrasound guidance, there is improvement in the sensory and motor blockade obtained with stimulating popliteal catheters versus those placed without nerve stimulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 21, 2012

Status Verified

June 1, 2012

Enrollment Period

2.2 years

First QC Date

January 13, 2010

Last Update Submit

June 20, 2012

Conditions

Foot SurgeryAnkle Surgery

Keywords

foot surgeryankle surgeryPatients scheduled for foot and ankle surgery

Outcome Measures

Primary Outcomes (1)

  • Complete motor and sensory anesthesia in the sciatic nerve distribution.

    Upon block placement

Study Arms (2)

Nerve stimulation and Ultrasound

ACTIVE COMPARATOR
Procedure: Placement of nerve block catheter

Ultrasound without nerve stimulation

ACTIVE COMPARATOR
Procedure: Placement of nerve block catheter

Interventions

Placement of nerve block catheterPROCEDURE

Placement of nerve block catheter with nerve stimulator and ultrasound

Nerve stimulation and Ultrasound

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled to undergo foot or ankle surgery at Mayo Clinic Jacksonville

You may not qualify if:

  • emergency surgery
  • peripheral neuropathy in the distribution of the sciatic nerve on the operative side
  • history of recent alcohol or drug abuse
  • allergy to local anesthetics
  • pregnancy
  • coagulopathy
  • subjects declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Study Officials

  • Christopher Robards, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 21, 2012

Record last verified: 2012-06

Locations

US(1)