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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376960
First Posted: June 20, 2011
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison

Resource links provided by NLM:


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 ]
    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 ]
  • Patient Satisfaction [ Time Frame: 48 hours postoperative ]
  • 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.

  • Narcotic Use [ Time Frame: Up to 30 days postoperative ]

Enrollment: 202
Study Start Date: June 2011
Study Completion Date: July 2016
Primary Completion Date: January 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376960


Locations
United States, North Carolina
OrthoCarolina, PA
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Principal Investigator: Bruce E Cohen, MD OrthoCarolina, PA
  More Information

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01376960     History of Changes
Other Study ID Numbers: 121809A
First Submitted: July 29, 2009
First Posted: June 20, 2011
Last Update Posted: August 22, 2016
Last Verified: August 2016

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