Foot SurgeryNCT06882109
The 5-in-2 Ankle Block for Outpatient Foot Surgery: the FIT Block Study
An observational study of Foot Surgery, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Surgery
- What is being tested?
- Five-in-two ankle block
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with FIT-Block for outpatient foot surgery
Who may be able to join
- Patients aged over 18 years old
- Scheduled for outpatient foot surgery and undergoing a FIT-block as regional anesthesia
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The 5-in-2 Ankle Block for Outpatient Foot Surgery: the FIT Block Descriptive Study
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
Read the detailed description
Foot surgery is frequently performed using regional anesthesia (RA). The ultrasound guided popliteal sciatic nerve block seems the gold standart technique. Improved ultrasound resolution and the development of early rehabilitation in outpatient surgery have led to the development of more distal RA techniques, at the ankle.
The ankle blocks are well described and provide similar anesthetic quality and surgical comfort than the popliteal sciatic nerve block. However, it has been reported that successful surgical anesthesia with ankle block was not reached in 14% to 16% of patients scheduled for hallux valgus surgery. Interestingly, these distal blocks preserve extrinsic motor function of the foot, enabling the patient to ambulate while minimizing the risk of falling.
Distal blocks using repeated punctures close to the periostum are painful during the RA performance. Sensitivity is greater at limbs extremities, as evidenced by Penfield's homonculus and the size of the brain surface devoted to extremities. As a result, it is frequently necessary to sedate the patient during the regional anesthesia procedure. The position of the ankle tourniquet may also require sedation if the surgery is to be prolonged.
For foot surgery under ankle blocks, it is necessary to anesthetize all distal branches of the sciatic nerve, i.e. the superficial and deep fibular nerves, the tibial nerve and the sural nerve. The saphenous nerve, coming from the lumbar plexus, is anesthetized with an ankle skin infiltration.
In the classical approaches, the tibial nerve is blocked at the medial aspect of the ankle, in the medial retro-malleolar region, posterior to tibial vessels. The sural nerve is blocked superficially in the lateral retro-malleolar region, between the calcaneal tendon and the lateral malleolus. The deep fibular nerve is located on the anterior surface of the instep, next to the periosteum, particularly painful when encountered by the needle. The superficial fibular nerve is located on the anterolateral aspect of the leg, where it is already divided into its two distal branches. Sometimes not visualized on ultrasound, these branches can be blocked by subcutaneous infiltration. This presents a risk of failure due to the anatomical variability of their emergence, explaining the risk of sensory blockade failure, as well as a theoretical risk of accidental injury during infiltration.
Optimized ultrasound guided approach for the FIT Block will be used, 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.
- Conditions
- Foot Surgery
- Being tested
- Five-in-two ankle block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five-in-two ankle blockOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete motor and sensory blocks
Complete motor and sensory blocks required for surgery under exclusive regional anesthesia by 5-in-2 ankle block
Measured: From 30 min after regional anesthesia to discharge from the operating room
Secondary outcomes (4)
Duration of the 5-in-2 ankle block
Delay before the resolution of motor and sensory blocks
Measured: From 30 min after regional anesthesia to 24 hours after surgery
Pain intensity
Measured by Visual Analogue Scale (VAS) at rest and during movement from 0 (no pain) to 10 (worst pain).
Measured: From leaving the operating room to 24 hours after surgery
Morphine sulfate consumption
The total morphine sulfate consumption from the operating room discharge to 24 hours after surgery
Measured: From leaving the operating room to 24 hours after surgery
Patient satisfaction
Assessed by EVAN-LR questionnaire (Evaluation du Vécu de l'Anesthésie LocoRégionale) from 0 (worst satisfaction) to 10 (best satisfaction).
Measured: The day after surgery (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAPDEVILA Xavier, University Hospital, Montpellier
- Investigators
- Lucas Deffontis, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882109
- Sponsor's protocol ID
- IORG0010765
- Other IDs
- CER-2024-XC01
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 5-in-2 Ankle Block for Outpatient Foot Surgery: the FIT Block Descriptive Study
- ClinicalTrials.gov ID
- NCT06882109
- Acronym / sponsor ID
- IORG0010765
- Conditions
- Foot Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Foot surgery is frequently performed using regional anesthesia (RA). The ultrasound guided popliteal sciatic nerve block seems the gold standart technique. Improved ultrasound resolution and the development of early rehabilitation in outpatient surgery have led to the development of more distal RA techniques, at the ankle.
The ankle blocks are well described and provide similar anesthetic quality and surgical comfort than the popliteal sciatic nerve block. However, it has been reported that successful surgical anesthesia with ankle block was not reached in 14% to 16% of patients scheduled for hallux valgus surgery. Interestingly, these distal blocks preserve extrinsic motor function of the foot, enabling the patient to ambulate while minimizing the risk of falling.
Distal blocks using repeated punctures close to the periostum are painful during the RA performance. Sensitivity is greater at limbs extremities, as evidenced by Penfield's homonculus and the size of the brain surface devoted to extremities. As a result, it is frequently necessary to sedate the patient during the regional anesthesia procedure. The position of the ankle tourniquet may also require sedation if the surgery is to be prolonged.
For foot surgery under ankle blocks, it is necessary to anesthetize all distal branches of the sciatic nerve, i.e. the superficial and deep fibular nerves, the tibial nerve and the sural nerve. The saphenous nerve, coming from the lumbar plexus, is anesthetized with an ankle skin infiltration.
In the classical approaches, the tibial nerve is blocked at the medial aspect of the ankle, in the medial retro-malleolar region, posterior to tibial vessels. The sural nerve is blocked superficially in the lateral retro-malleolar region, between the calcaneal tendon and the lateral malleolus. The deep fibular nerve is located on the anterior surface of the instep, next to the periosteum, particularly painful when encountered by the needle. The superficial fibular nerve is located on the anterolateral aspect of the leg, where it is already divided into its two distal branches. Sometimes not visualized on ultrasound, these branches can be blocked by subcutaneous infiltration. This presents a risk of failure due to the anatomical variability of their emergence, explaining the risk of sensory blockade failure, as well as a theoretical risk of accidental injury during infiltration.
Optimized ultrasound guided approach for the FIT Block will be used, 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with FIT-Block for outpatient foot surgery
Key inclusion criteria (2 listed)
- Patients aged over 18 years old
- Scheduled for outpatient foot surgery and undergoing a FIT-block as regional anesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Five-in-two ankle blockThe 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. | Other | – |
Primary outcome
Complete motor and sensory blocks
Time frame: From 30 min after regional anesthesia to discharge from the operating room
Complete motor and sensory blocks required for surgery under exclusive regional anesthesia by 5-in-2 ankle block
4 secondary outcomes
Duration of the 5-in-2 ankle block
Time frame: From 30 min after regional anesthesia to 24 hours after surgery
Pain intensity
Time frame: From leaving the operating room to 24 hours after surgery
Morphine sulfate consumption
Time frame: From leaving the operating room to 24 hours after surgery
Patient satisfaction
Time frame: The day after surgery (24 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucas Deffontis, MD principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Surgery, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Bringuier, MD, PhD (+33467338661, s-bringuierbranchereau@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete motor and sensory blocks (time frame: From 30 min after regional anesthesia to discharge from the operating room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.