Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Specific Block of the Plantar Branches of the Tibial Nerve Under Ultrasound for Foot Surgery : A Monocentric Pilot Study

Conditions
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Hallux Valgus and Bunion (Disorder), Morton Neuroma, Metatarsal Fracture, Ingrown Nail, Foot Wound, Foot Infection

Intervention / Treatment
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* Procedure: Specific block of medial and lateral plantar nerves


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a foot surgery Consent for participation Affiliation to the french social security system Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal tibial nerve block<br>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<br>* Specific injection of long duration local anesthetic in contact with medial and lateral plantar nerves. Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foot surgery, Regional Anesthesia, Regional Analgesia, Ultrasound, Distal block, Plantar nerve block