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

NCT03504462 | Completed

• 1 other identifier: 2018/03
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Foot surgery; Regional Anesthesia; Regional Analgesia; Ultrasound; Distal block; Plantar nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Feasibility of the foot surgery with a specific block of the lateral and medial plantar nerves

  40 minutes

• Ability to recognize plantar nerves under ultrasound

  40 minutes

• Patient satisfaction

  At the end of surgery (2 hours maximum)

• Patient comfort during block performance

  40 minutes

• Complication

  Day 15 and Day 30 After Surgery

Study Arms (1)

Distal tibial nerve block

EXPERIMENTAL

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

Interventions

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.

Distal tibial nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a foot surgery
• Consent for participation
• Affiliation to the french social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

CMC Ambroise Paré

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

Location

MeSH Terms

Conditions

Hallux Valgus; Bunion; Morton Neuroma; Nails, Ingrown; Foot Injuries

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Acquired; Metatarsalgia; Foot Diseases; Joint Diseases; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Injuries; Wounds and Injuries

Study Officials

• Sébastien Bloc, MD

  CMC Ambroise Paré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 20, 2018
• Study Start: June 25, 2018
• Primary Completion: September 25, 2019
• Study Completion: October 23, 2019
• Last Updated: June 29, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)