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

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

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.

Study Overview

• Status: Completed
• Conditions: Morton Neuroma; Ingrown Nail; Metatarsal Fracture; Foot Infection; Hallux Valgus and Bunion (Disorder); Foot Wound
• Intervention / Treatment: Procedure: Specific block of medial and lateral plantar nerves

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).

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Neuilly-sur-Seine, Ile-de-France, France, 92200
      • CMC Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré
• Investigators: Principal Investigator: Sébastien Bloc, MD, CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): October 23, 2019

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Ultrasound; Regional Anesthesia; Foot surgery; Regional Analgesia; Distal block; Plantar nerve block
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Foot Diseases; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Neuralgia; Nail Diseases; Nerve Sheath Neoplasms; Foot Deformities; Metatarsalgia; Neuroma; Hallux Valgus; Morton Neuroma; Nails, Ingrown
• Other Study ID Numbers: 2018/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No