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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Forefoot Surgery
• Intervention / Treatment: Procedure: elective forefoot surgery

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • OrthoCarolina, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale (VAS)		24 hours postoperatively
Patient Satisfaction		48 hours postoperative
Length of Post Anesthesia Care Unit (PACU) stay	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.	Up to 6 hours postoperative
Narcotic Use		Up to 30 days postoperative

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Investigators: Principal Investigator: Bruce E Cohen, MD, OrthoCarolina, PA

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: July 29, 2009
• First Submitted That Met QC Criteria: June 17, 2011
• First Posted (ESTIMATE): June 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2016
• Last Update Submitted That Met QC Criteria: August 19, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: forefoot surgery; Ankle Block; Popliteal Fossa Block
• Other Study ID Numbers: 121809A