An interventional study of Specific block of medial and lateral plantar nerves in Hallux Valgus and Bunion (Disorder), Morton Neuroma and Metatarsal Fracture, sponsored by CMC Ambroise Paré. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Other
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.
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).
Exclusion Criteria:
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
Procedure: Specific block of medial and lateral plantar nerves
Specific injection of long duration local anesthetic in contact with medial and lateral plantar nerves. Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve.
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
Time frame: 40 minutes
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
Time frame: 40 minutes
Ability to Recognize Plantar Nerves Under Ultrasound
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
Time frame: 40 minutes
Patient Satisfaction
Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)
Time frame: 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)
Time frame: 40 minutes
Complication
Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.
Time frame: Day 15 and Day 30 After Surgery
| Milestone | Distal Tibial Nerve Block |
|---|---|
| Started | 27 |
| Completed | 27 |
| Not completed | 0 |
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
| Participants | Distal Tibial Nerve Block |
|---|---|
| Success of distal tibial nerve block — Success of distal tibial nerve block | 3 |
| Medial plantar nerve block — Success of distal tibial nerve block | 23 |
| Lateral plantar nerve block — Success of distal tibial nerve block | 3 |
| Calcaneal nerve block — Success of distal tibial nerve block | 0 |
Usage (or not) of an additional anesthetic procedure to perform the surgery
| Participants | Distal Tibial Nerve Block |
|---|---|
| Need for additional anesthetic procedure | 8 |
| No additional anesthetic procedure | 19 |
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
| Score on a scale | Distal Tibial Nerve Block |
|---|---|
| Ability to Recognize Plantar Nerves Under Ultrasound | 80 (60 to 100) |
Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)
| Score on a scale | Distal Tibial Nerve Block |
|---|---|
| Patient Satisfaction | 100 (100 to 100) |
Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
| Score on a scale | Distal Tibial Nerve Block |
|---|---|
| Patient Comfort During Block Performance | 45 ± 19 |
Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.
| Participants | Distal Tibial Nerve Block |
|---|---|
| Day15 - Paresthesia | 8 |
| Day15 - Decreased foot sensitivity | 6 |
| Day15 - Difficulty in toe mobility | 1 |
| Day15 - Edema/Hematoma | 3 |
| Day30 - Paresthesia | 0 |
| Day30 - Decreased foot sensitivity | 0 |
| Day30 - Difficulty in toe mobility | 0 |
| Day30 - Edema/Hematoma | 3 |
Collected over from enrollment until end of follow-up, up to 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Distal Tibial Nerve Block | 0/27 (0%) | 0/27 (0%) | 9/27 (33.3%) |
| Event | Distal Tibial Nerve Block |
|---|---|
| ParesthesiaNervous system disorders | 8/27 |
| Loss of sensationNervous system disorders | 6/27 |
| Edema or HematomaGeneral disorders | 3/27 |
| Age, Continuous(years) | Distal Tibial Nerve Block |
|---|---|
| Mean | 52 ± 18 |
| Sex: Female, Male(Participants) | Distal Tibial Nerve Block |
|---|---|
| Female | 21 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | Distal Tibial Nerve Block |
|---|
| Type of surgery(Participants) | Distal Tibial Nerve Block |
|---|---|
| Bunionectomy | 8 |
| First metatarsophalangeal (MTP-1) joint arthrodesis | 6 |
| Ingrown toenail surgery | 4 |
| Extensor tendon synovectomy | 1 |
| Metal implant removal | 1 |
| Great toe tumor excision | 1 |
| Cyst exeresis between the 3rd and the 4th metatarsals | 1 |
| Bunionectomy + Osteotomies of the 2nd to 3rd, 4th or 5th metatarsals | 3 |
| MTP-1 joint arthrodesis + Tenotomy on the 3rd toe | 1 |
| Great toe tumor excision + arthroplasty on the 5th toe | 1 |
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CMC Ambroise Paré