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NCT01376960 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by OrthoCarolina Research Institute.

Completed
Registry status
Phase 4
Development phase
202
Enrollment target

NCT01376960: Completed Phase 4 study, sponsored by OrthoCarolina Research Institute.

NCT01376960 is a Phase 4 study that has completed, run by OrthoCarolina Research Institute. The registered enrollment target is 202 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01376960, a Phase 4 study, has completed, sponsored by OrthoCarolina Research Institute.

COMPLETED
Registry status
Phase 4
Development phase
202 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • PROCEDURE elective forefoot surgery

Trial Details

FieldValue
Enrollment Target 202 participants
Start Date 2011-06
Est. Completion 2016-07
Phase Phase 4
OrthoCarolina Research Institute

28 total trials

What the finished NCT01376960 record still lists

NCT01376960 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 1 intervention - of which elective forefoot surgery is the first listed.

NCT01376960 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01376960 about?

NCT01376960 is a clinical study titled "Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures". 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 followi...

What is the current status of trial NCT01376960?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 202 participants. The study started on 2011-06. Estimated completion is 2016-07.

What interventions are being tested in trial NCT01376960?

The interventions under investigation include: elective forefoot surgery (PROCEDURE).

Who is sponsoring clinical trial NCT01376960?

This trial is sponsored by OrthoCarolina Research Institute, which has 28 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01376960's enrollment target sits among peer trials

202 404th of 2000 higher than 1,595 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01376960, the US trial registry maintained by the National Library of Medicine. NCT01376960 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.