Foot Infection, Foot Wound, Hallux Valgus and Bunion (Disorder), Ingrown Nail, Metatarsal Fracture, Morton Neuroma
Conditions
Keywords
Foot surgery, Regional Anesthesia, Regional Analgesia, Ultrasound, Distal block, Plantar nerve block
Brief 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. 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).
Interventions
Specific injection of long duration local anesthetic in contact with medial and lateral plantar nerves. Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Foot Surgery With a Specific Block of the Lateral and Medial Plantar Nerves | 40 minutes | Usage (or not) of an additional anesthetic procedure to perform the surgery |
| Ability to Recognize Plantar Nerves Under Ultrasound | 40 minutes | Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy) |
| Patient Satisfaction | At the end of surgery (2 hours maximum) | Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied) |
| Patient Comfort During Block Performance | 40 minutes | Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain) |
| Complication | Day 15 and Day 30 After Surgery | Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling. |
Countries
France
Contacts
CMC Ambroise Paré
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 18 |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 6 Participants |
| Type of surgery Bunionectomy | 8 Participants |
| Type of surgery Bunionectomy + Osteotomies of the 2nd to 3rd, 4th or 5th metatarsals | 3 Participants |
| Type of surgery Cyst exeresis between the 3rd and the 4th metatarsals | 1 Participants |
| Type of surgery Extensor tendon synovectomy | 1 Participants |
| Type of surgery First metatarsophalangeal (MTP-1) joint arthrodesis | 6 Participants |
| Type of surgery Great toe tumor excision | 1 Participants |
| Type of surgery Great toe tumor excision + arthroplasty on the 5th toe | 1 Participants |
| Type of surgery Ingrown toenail surgery | 4 Participants |
| Type of surgery Metal implant removal | 1 Participants |
| Type of surgery MTP-1 joint arthrodesis + Tenotomy on the 3rd toe | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 9 / 27 |
| serious Total, serious adverse events | 0 / 27 |