Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Distal tibial nerve block | Experimental | Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific block of medial and lateral plantar nerves | Procedure | Specific injection of long duration local anesthetic in contact with medial and lateral plantar nerves. Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 40 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 40 minutes |
| Ability to Recognize Plantar Nerves Under Ultrasound |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sébastien Bloc, MD | CMC Ambroise Paré | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Distal Tibial Nerve Block | Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
| 40 minutes |
| Patient Satisfaction | Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied) | 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) | 40 minutes |
| Complication | Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling. | Day 15 and Day 30 After Surgery |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Distal Tibial Nerve Block | Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Type of surgery | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 40 minutes |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 40 minutes |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Ability to Recognize Plantar Nerves Under Ultrasound | Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy) | 1 missing data | Posted | Median | Inter-Quartile Range | Score on a scale | 40 minutes |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Patient Satisfaction | Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied) | Posted | Median | Inter-Quartile Range | Score on a scale | At the end of surgery (2 hours maximum) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Patient Comfort During Block Performance | Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain) | 1 missing data | Posted | Mean | Standard Deviation | Score on a scale | 40 minutes |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Complication | Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling. | Posted | Count of Participants | Participants | Day 15 and Day 30 After Surgery |
|
|
from enrollment until end of follow-up, up to 30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Distal Tibial Nerve Block | Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve | 0 | 27 | 0 | 27 | 9 | 27 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Edema or Hematoma | General disorders | Systematic Assessment |
| ||
| Loss of sensation | Nervous system disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sébastien BLOC | CMC Ambroise Paré Hartmann | 0146415079 | +33 | recherche@clinique-a-pare.fr |
| Apr 24, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D000071378 | Bunion |
| D000070607 | Morton Neuroma |
| D009263 | Nails, Ingrown |
| D018409 | Foot Injuries |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005531 | Foot Deformities, Acquired |
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D007592 | Joint Diseases |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
Not provided
Not provided
|
| Ingrown toenail surgery |
|
| Extensor tendon synovectomy |
|
| Metal implant removal |
|
| Great toe tumor excision |
|
| Cyst exeresis between the 3rd and the 4th metatarsals |
|
| Bunionectomy + Osteotomies of the 2nd to 3rd, 4th or 5th metatarsals |
|
| MTP-1 joint arthrodesis + Tenotomy on the 3rd toe |
|
| Great toe tumor excision + arthroplasty on the 5th toe |
|
|
| Calcaneal nerve block |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories |
|---|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Day15 - Paresthesia |
| |||||
| Day15 - Decreased foot sensitivity |
| |||||
| Day15 - Difficulty in toe mobility |
| |||||
| Day15 - Edema/Hematoma |
| |||||
| Day30 - Paresthesia |
| |||||
| Day30 - Decreased foot sensitivity |
| |||||
| Day30 - Difficulty in toe mobility |
| |||||
| Day30 - Edema/Hematoma |
|