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

NCT06882109 | Not Yet Recruiting

• 2 other identifiers: IORG0010765CER-2024-XC01
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Complete motor and sensory blocks

  Complete motor and sensory blocks required for surgery under exclusive regional anesthesia by 5-in-2 ankle block

  From 30 min after regional anesthesia to discharge from the operating room

Secondary Outcomes (4)

• Duration of the 5-in-2 ankle block

  From 30 min after regional anesthesia to 24 hours after surgery

• Pain intensity

  From leaving the operating room to 24 hours after surgery

• Morphine sulfate consumption

  From leaving the operating room to 24 hours after surgery

• Patient satisfaction

  The day after surgery (24 hours)

Interventions

Five-in-two ankle block OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with FIT-Block for outpatient foot surgery

You may qualify if:

• Patients aged over 18 years old
• Scheduled for outpatient foot surgery and undergoing a FIT-block as regional anesthesia

You may not qualify if:

• Severe coagulopathy
• Peripheral neuropathy or chronic pain syndrome
• Infection or injury at the needle entry points
• Allergy or contraindications to study drugs
• Pregnancy or breastfeeding woman
• Inability to participate in pain scoring scales

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Officials

• Lucas Deffontis, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Bringuier, MD, PhD

CONTACT

+33467338661; s-bringuierbranchereau@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: (MD, PhD) Principal investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 18, 2025
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share