Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03504462
Acronym
DISTIB
Enrollment
27
Registered
2018-04-20
Start date
2018-06-25
Completion date
2019-10-23
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

PROCEDURESpecific 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.

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves40 minutesPinprick 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

MeasureTime frameDescription
Feasibility of the Foot Surgery With a Specific Block of the Lateral and Medial Plantar Nerves40 minutesUsage (or not) of an additional anesthetic procedure to perform the surgery
Ability to Recognize Plantar Nerves Under Ultrasound40 minutesNumeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
Patient SatisfactionAt the end of surgery (2 hours maximum)Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)
Patient Comfort During Block Performance40 minutesNumeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
ComplicationDay 15 and Day 30 After SurgeryQuestionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSébastien Bloc, MD

CMC Ambroise Paré

Baseline characteristics

Characteristic
Age, Continuous52 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 typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 27
other
Total, other adverse events
9 / 27
serious
Total, serious adverse events
0 / 27

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026