Hallux Valgus and Bunion (Disorder)DISTIBNCT03504462
Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery
A study testing Specific block of medial and lateral plantar nerves in people with Hallux Valgus and Bunion (Disorder) and Morton Neuroma, run by CMC Ambroise Paré at 1 site in France.
Trial summary
Foot surgery is a painful surgery that is usually scheduled in outpatients. A good management of analgesia is the crucial point. Regional anesthesia (RA) is the gold standard, that provides good anesthesia and a long duration of analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus and Bunion (Disorder), Morton Neuroma, Metatarsal Fracture
- What is being tested?
- Specific block of medial and lateral plantar nerves
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2018to 23 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients undergoing a foot surgery
- Consent for participation
- Affiliation to the french social security system
Who cannot join
- Patient's refusal
- Existence of major spontaneous or acquired haemostatic disorders
- Infection at the point of puncture
- Allergy to local anesthetic or analgesic
- Pregnant or likely to be pregnant
- Patients under protection of the adults (guardianship, curator or safeguard of justice)
- Patients whose cognitive state does not allow assessment by the scales used
- Neuropathic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specific Block of the Plantar Branches of the Tibial Nerve Under Ultrasound for Foot Surgery : A Monocentric Pilot Study
Foot surgery is a painful surgery that is usually scheduled in outpatients. A good management of analgesia is the crucial point. Regional anesthesia (RA) is the gold standard, that provides good anesthesia and a long duration of analgesia. The sciatic nerve block (or its branches) is the most adapted analgesic technique.
Limitation of proximal sciatic block is the motor block of the ankle and results in the impossibility, for the patient, to walk during the early post-operative period. Distal block of the sciatic nerve (tibial and fibular nerve blocks), at the level of the ankle, has been proposed to maintain the mobility of the ankle, to make deambulation with crutches easier. Nevertheless, the lack of sensibility of the heel remains a limitation for early walking, even with adapted shoes (ie : Barouk).
Read more
A specific anesthesia of the distal part of the foot, respecting the heel, could be the best option to provide an early deambulation and a suitable analgesia.
Ultrasound identification and specific anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves) could meet this dual objective : good anesthesia and suitable analgesia for early deambulation.
This study is a feasibility study of a specific block of the plantar branches of the tibial nerve, to preserve the sensibility of the heel, in case of foot surgery. The safety of the procedure will be assessed according to the rate of postoperative dysesthesia.
Read the detailed description
Block of the medial and lateral plantar branches of the tibial nerve will be performed under the medial malleolar-calcaneal axis (MMCA) in order to preserve the calcaneal nerves.
Blocks of the deep peroneal nerve (DPN) and the superficial peroneal nerve (SPN) will be added to provide an adequate anesthesia.
Every block will be performed under Ultrasound using a 27-gauge, 5-cm, short bevel needle.
5 mL of 0.375% Ropivacaine will be injected for each block. The sensory blocks will be assessed by pinprick test and cold test every 10 minutes for 40 minutes in the following locations: Calcaneal nerves, Lateral plantar nerve and Medial plantar nerve.
The extent of sensory block will be graded as follows: 2: normal sensation; 1: decreased sensation; and 0: no sensation (complete block).
- Conditions
- Hallux Valgus and Bunion (Disorder), Morton Neuroma, Metatarsal Fracture, Ingrown Nail, Foot Wound, Foot Infection
- Being tested
- Specific block of medial and lateral plantar nerves
- Keywords
- Foot surgery, Regional Anesthesia, Regional Analgesia, Ultrasound, Distal block, Plantar nerve block
- Medical subject headings
- Hallux Valgus, Bunion, Morton Neuroma, Nails, Ingrown, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific block of medial and lateral plantar nervesProcedure or surgery
Specific injection of long duration local anesthetic in contact with medial and lateral plantar nerves.
Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve.
| Study group | Role | What they receive |
|---|---|---|
| Distal tibial nerve block | Experimental | Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve Receives: Procedure: Specific block of medial and lateral plantar nerves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves
Pinprick and cold test on the sole of the foot - Cartography of the sole - Ipsilateral versus Contralateral test Numeric Scale for Pin-Prick test and Cold test : 2: normal sensation, 1: decreased sensation, 0: total loss of sensation Success of distal tibial nerve block is defined as complete anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves), with preservation of the heel : medial plantar nerve area score = 0; lateral plantar nerve area score = 0; calcaneal nerve area score = 2
Measured: 40 minutes
Secondary outcomes (5)
Feasibility of the Foot Surgery With a Specific Block of the Lateral and Medial Plantar Nerves
Usage (or not) of an additional anesthetic procedure to perform the surgery
Measured: 40 minutes
Ability to Recognize Plantar Nerves Under Ultrasound
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
Measured: 40 minutes
Patient Satisfaction
Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)
Measured: At the end of surgery (2 hours maximum)
Patient Comfort During Block Performance
Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
Measured: 40 minutes
Complication
Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.
Measured: Day 15 and Day 30 After Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start25 Jun 2018
- Primary completion25 Sep 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hallux Valgus and Bunion (Disorder)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien Bloc, MD, Principal investigator, CMC Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504462
- Sponsor's protocol ID
- 2018/03
- Acronym
- DISTIB
- Status last verified
- Dec 2019
- First submitted
- 4 Apr 2018
- Last updated
- 12 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Block of the Plantar Branches of the Tibial Nerve Under Ultrasound for Foot Surgery : A Monocentric Pilot Study
- ClinicalTrials.gov ID
- NCT03504462
- Acronym / sponsor ID
- DISTIB / 2018/03
- Conditions
- Hallux Valgus and Bunion (Disorder), Morton Neuroma, Metatarsal Fracture, Ingrown Nail, Foot Wound, Foot Infection
- Keywords
- Foot surgery, Regional Anesthesia, Regional Analgesia, Ultrasound, Distal block, Plantar nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Posted 12 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Foot surgery is a painful surgery that is usually scheduled in outpatients. A good management of analgesia is the crucial point. Regional anesthesia (RA) is the gold standard, that provides good anesthesia and a long duration of analgesia. The sciatic nerve block (or its branches) is the most adapted analgesic technique.
Limitation of proximal sciatic block is the motor block of the ankle and results in the impossibility, for the patient, to walk during the early post-operative period. Distal block of the sciatic nerve (tibial and fibular nerve blocks), at the level of the ankle, has been proposed to maintain the mobility of the ankle, to make deambulation with crutches easier. Nevertheless, the lack of sensibility of the heel remains a limitation for early walking, even with adapted shoes (ie : Barouk).
A specific anesthesia of the distal part of the foot, respecting the heel, could be the best option to provide an early deambulation and a suitable analgesia.
Ultrasound identification and specific anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves) could meet this dual objective : good anesthesia and suitable analgesia for early deambulation.
This study is a feasibility study of a specific block of the plantar branches of the tibial nerve, to preserve the sensibility of the heel, in case of foot surgery. The safety of the procedure will be assessed according to the rate of postoperative dysesthesia.
Detailed description
Block of the medial and lateral plantar branches of the tibial nerve will be performed under the medial malleolar-calcaneal axis (MMCA) in order to preserve the calcaneal nerves.
Blocks of the deep peroneal nerve (DPN) and the superficial peroneal nerve (SPN) will be added to provide an adequate anesthesia.
Every block will be performed under Ultrasound using a 27-gauge, 5-cm, short bevel needle.
5 mL of 0.375% Ropivacaine will be injected for each block. The sensory blocks will be assessed by pinprick test and cold test every 10 minutes for 40 minutes in the following locations: Calcaneal nerves, Lateral plantar nerve and Medial plantar nerve.
The extent of sensory block will be graded as follows: 2: normal sensation; 1: decreased sensation; and 0: no sensation (complete block).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distal tibial nerve block | Experimental | Procedure: Specific block of medial and lateral plantar nervesPatient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing a foot surgery
- Consent for participation
- Affiliation to the french social security system
Key exclusion criteria (8 listed)
- Patient's refusal
- Existence of major spontaneous or acquired haemostatic disorders
- Infection at the point of puncture
- Allergy to local anesthetic or analgesic
- Pregnant or likely to be pregnant
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 |
|---|---|---|
| Specific block of medial and lateral plantar nervesSpecific injection of long duration local anesthetic in contact with medial and lateral plantar nerves. Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve. | Procedure or surgery | Distal tibial nerve block |
Primary outcome
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves
Time frame: 40 minutes
Pinprick and cold test on the sole of the foot - Cartography of the sole - Ipsilateral versus Contralateral test Numeric Scale for Pin-Prick test and Cold test : 2: normal sensation, 1: decreased sensation, 0: total loss of sensation Success of distal tibial nerve block is defined as complete anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves), with preservation of the heel : medial plantar nerve area score = 0; lateral plantar nerve area score = 0; calcaneal nerve area score = 2
5 secondary outcomes
Feasibility of the Foot Surgery With a Specific Block of the Lateral and Medial Plantar Nerves
Time frame: 40 minutes
Ability to Recognize Plantar Nerves Under Ultrasound
Time frame: 40 minutes
Patient Satisfaction
Time frame: At the end of surgery (2 hours maximum)
Patient Comfort During Block Performance
Time frame: 40 minutes
Complication
Time frame: Day 15 and Day 30 After Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Sébastien Bloc, MD principal investigator
CMC Ambroise Paré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific block of medial and lateral plantar nerves in people with Hallux Valgus and Bunion (Disorder) and Morton Neuroma, run by CMC Ambroise Paré at 1 site in France.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 12 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves (time frame: 40 minutes). 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 12 Jun 2026.