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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Anesthesia
Forefoot Surgery
Procedure: elective forefoot surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 101
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: single shot popliteal fossa block Procedure: elective forefoot surgery
Includes both soft-tissue and osseous procedures.
Active Comparator: ankle blocks Procedure: elective forefoot surgery
Includes both soft-tissue and osseous procedures.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376960

Contacts
Contact: Susan M Odum, MEd,MEd,CCRC 704-323-2265 susan.odum@orthocarolina.com

Locations
United States, North Carolina
OrthoCarolina, PA Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Susan M Odum, MEd,MEd,CCRC    704-323-2265    susan.odum@orthocarolina.com   
Principal Investigator: Bruce E Cohen, MD         
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Principal Investigator: Bruce E Cohen, MD OrthoCarolina, PA
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01376960     History of Changes
Other Study ID Numbers: 121809A
Study First Received: July 29, 2009
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by OrthoCarolina Research Institute, Inc.:
forefoot surgery
Ankle Block
Popliteal Fossa Block

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014