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

NCT ID: NCT03504462

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-25
• Study Completion Date: 2019-10-23

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).

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Distal tibial nerve block

Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve

Group Type: EXPERIMENTAL

Specific block of medial and lateral plantar nerves

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien Bloc, MD

Role: PRINCIPAL_INVESTIGATOR

CMC Ambroise Paré

Locations

CMC Ambroise Paré

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

Countries

France

Other Identifiers

2018/03

Identifier Type: -

Identifier Source: org_study_id