NCT01376960

Brief Summary

The purpose of this study is to compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The primary outcome variable for this study is the percentage of patients that convert to general anesthesia following either a single shot popliteal fossa block or ankle block. H0: There is no difference in the percentage of patients that convert to general anesthesia between single shot popliteal fossa blocks and ankle blocks. HA: There will be a lower percentage of patients receiving a single shot popliteal fossa block that convert to general anesthesia compared to patients receiving an ankle block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
202

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2011

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

3.6 years

First QC Date

July 29, 2009

Last Update Submit

August 19, 2016

Conditions

AnesthesiaForefoot Surgery

Keywords

forefoot surgeryAnkle BlockPopliteal Fossa Block

Outcome Measures

Primary Outcomes (1)

  • Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block

    Popliteal fossa and ankle blocks are types of anesthesia used during surgery. If these methods are not effective as an anesthetic during surgery the anethesiologist will convert to general anesthesia.

    Participants will be followed for the duration of the surgery, an expected average of 2 hours

Secondary Outcomes (4)

  • Visual Analog Pain Scale (VAS)

    24 hours postoperatively

  • Patient Satisfaction

    48 hours postoperative

  • Length of Post Anesthesia Care Unit (PACU) stay

    Up to 6 hours postoperative

  • Narcotic Use

    Up to 30 days postoperative

Study Arms (2)

single shot popliteal fossa block

ACTIVE COMPARATOR
Procedure: elective forefoot surgery

ankle blocks

ACTIVE COMPARATOR
Procedure: elective forefoot surgery

Interventions

elective forefoot surgeryPROCEDURE

Includes both soft-tissue and osseous procedures.

ankle blockssingle shot popliteal fossa block

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures

You may not qualify if:

  • Diabetes
  • Any form of Peripheral neuropathy
  • Known allergy to local anesthesia
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OrthoCarolina, PA

Charlotte, North Carolina, 28203, United States

Location

Study Officials

  • Bruce E Cohen, MD

    OrthoCarolina, PA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2009

First Posted

June 20, 2011

Study Start

June 1, 2011

Primary Completion

January 1, 2015

Study Completion

July 1, 2016

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

US(1)