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NCT Number: NCT01376960

Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures

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.

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Key information

Conditions

Anesthesia Forefoot Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina, PA

Charlotte, North Carolina, 28203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

elective forefoot surgery

Procedure

Includes both soft-tissue and osseous procedures.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Visual Analog Pain Scale (VAS)

    Time frame: 24 hours postoperatively

  2. Patient Satisfaction

    Time frame: 48 hours postoperative

  3. Length of Post Anesthesia Care Unit (PACU) stay

    Time frame: Up to 6 hours postoperative

    Length of PACU stay is calculated from the time the patient is taken from the operative suite to PACU, ie recovery, to the time the patient leaves PACU.

  4. Narcotic Use

    Time frame: Up to 30 days postoperative

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Jun 20, 2011
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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