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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01376960
Enrollment
202
Registered
2011-06-20
Start date
2011-06-30
Completion date
2016-07-31
Last updated
2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Forefoot Surgery

Keywords

forefoot surgery, Ankle Block, Popliteal Fossa Block

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.

Interventions

PROCEDUREelective forefoot surgery

Includes both soft-tissue and osseous procedures.

Sponsors

OrthoCarolina Research Institute, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Conversion to general anesthesia following either a single shot popliteal fossa block or ankle blockParticipants will be followed for the duration of the surgery, an expected average of 2 hoursPopliteal 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

MeasureTime frameDescription
Visual Analog Pain Scale (VAS)24 hours postoperatively
Patient Satisfaction48 hours postoperative
Length of Post Anesthesia Care Unit (PACU) stayUp to 6 hours postoperativeLength 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 UseUp to 30 days postoperative

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026