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

OrthoCarolina Research Institute, Inc.

Status and phase: Completed; Phase 4

Conditions: Forefoot Surgery; Anesthesia

Treatments: Procedure: elective forefoot surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01376960

121809A

Details and patient eligibility

About

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.

Enrollment: 202 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

single shot popliteal fossa block

Active Comparator group

Treatment:

Procedure: elective forefoot surgery

ankle blocks

Active Comparator group

Treatment:

Procedure: elective forefoot surgery