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The 5-in-2 Ankle Block for Outpatient Foot Surgery: the FIT Block Study

NCT06882109 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-03-18

No results posted yet for this study

Summary

Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.

Popliteal sciatic nerve block is widely used but at risk of falling due to prolonged motor blockade and foot drop. Ankle block is recognized as a good regional anesthesia technique but requires five skin punctures.

FIT block might be a good alternative, aiming to provide an optimal anesthetic block, good postoperative analgesia without motor blockade (calf muscles) and necessitating only two skin punctures.

The purpose of this study is to describe the technique and the efficacy and safety of the FIT block for outpatient foot surgery

Conditions

  • Foot Surgery

Interventions

OTHER

Five-in-two ankle block

The FIT block is a new approach for regional anesthetic block of the ankle. We use an optimized ultrasound guided approach for the FIT Block, based on optimal nerve anatomical locations. A one puncture proximal approach for the fibular nerves is used, while maintaining the benefit of preserved extrinsic motricity. Another one puncture approaches the sural nerve laterally, after the block of the tibial nerve during the same puncture and then the subcutaneous infiltration of the saphenous nerve. An anatomical proof of concept study has been done before the exploratory clinical study. These approaches permit a surgical anesthetic block for foot surgery using 2 punctures (instead of 5) with a single patient's body position, compatible with sedation.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Lucas Deffontis, MD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06882109 on ClinicalTrials.gov