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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01376960
• Other study ID #: 121809A
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2009
• Last updated: August 19, 2016
• Start date: June 2011
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: July 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Forefoot Surgery

Intervention

Procedure:
• elective forefoot surgery
Includes both soft-tissue and osseous procedures.

Locations

Country	Name	City	State
United States	OrthoCarolina, PA	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Visual Analog Pain Scale (VAS)		24 hours postoperatively	No
Secondary	Patient Satisfaction		48 hours postoperative	No
Secondary	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	No
Secondary	Narcotic Use		Up to 30 days postoperative	No