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NCT Number: NCT03504462

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

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.

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Key information

Conditions

Hallux Valgus and Bunion (Disorder) Bunion Foot Deformities Foot Deformities, Acquired Foot Diseases Foot Infection Foot Injuries Foot Wound Hallux Valgus Ingrown Nail Joint Diseases Leg Injuries Metatarsal Fracture Metatarsalgia Morton Neuroma Musculoskeletal Diseases Nail Diseases Nails, Ingrown Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves

    Time frame: 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 outcomes

  1. Feasibility of the Foot Surgery With a Specific Block of the Lateral and Medial Plantar Nerves

    Time frame: 40 minutes

    Usage (or not) of an additional anesthetic procedure to perform the surgery

  2. Ability to Recognize Plantar Nerves Under Ultrasound

    Time frame: 40 minutes

    Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)

  3. Patient Satisfaction

    Time frame: At the end of surgery (2 hours maximum)

    Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)

  4. Patient Comfort During Block Performance

    Time frame: 40 minutes

    Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)

  5. Complication

    Time frame: Day 15 and Day 30 After Surgery

    Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

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

Acronym: DISTIB

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2018
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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