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

Phase 4

Completed

• Conditions: Anesthesia; Forefoot Surgery
• Interventions: Procedure: elective forefoot surgery

• Registration Number: NCT01376960
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-29
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2015-01
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures

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Exclusion Criteria

• Diabetes
• Any form of Peripheral neuropathy
• Known allergy to local anesthesia
• Active infection

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ankle blocks	elective forefoot surgery	-
single shot popliteal fossa block	elective forefoot surgery	-

Primary Outcome Measures

Name	Time	Method
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block	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

Name	Time	Method
Visual Analog Pain Scale (VAS)	24 hours postoperatively
Patient Satisfaction	48 hours postoperative
Length of Post Anesthesia Care Unit (PACU) stay	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	Up to 30 days postoperative

Trial Locations

Locations (1)

OrthoCarolina, PA; 🇺🇸 Charlotte, North Carolina, United States