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

This study is currently recruiting participants.
Verified January 2012 by OrthoCarolina Research Institute, Inc.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01376960
First received: July 29, 2009
Last updated: October 10, 2012
Last verified: January 2012
History of Changes

July 29, 2009
October 10, 2012
June 2011
June 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block [ Time Frame: Between the time surgery begins to the time that surgery ends ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01376960 on ClinicalTrials.gov Archive Site
  • Visual Analog Pain Scale (VAS) [ Time Frame: 24 hours postoperatively ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 48 hours postoperative ] [ Designated as safety issue: No ]
  • Length of Post Anesthesia Care Unit (PACU) stay [ Time Frame: Up to 6 hours postoperative ] [ Designated as safety issue: No ]
    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.
  • Narcotic Use [ Time Frame: Up to 30 days postoperative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures
Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anesthesia
  • Forefoot Surgery
Procedure: elective forefoot surgery
Includes both soft-tissue and osseous procedures.
  • Active Comparator: single shot popliteal fossa block
    Intervention: Procedure: elective forefoot surgery
  • Active Comparator: ankle blocks
    Intervention: Procedure: elective forefoot surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
101
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Susan M Odum, MEd,MEd,CCRC 704-323-2265 susan.odum@orthocarolina.com
United States
 
NCT01376960
121809A
Yes
OrthoCarolina Research Institute, Inc.
OrthoCarolina Research Institute, Inc.
Not Provided
Principal Investigator: Bruce E Cohen, MD OrthoCarolina, PA
OrthoCarolina Research Institute, Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP