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

Morton Neuroma Clinical Trial

— DISTIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504462
• Other study ID #: 2018/03
• Status: Completed
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: October 23, 2019

Study information

• Verified date: December 2019
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 23, 2019
• Est. primary completion date: September 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Ability to recognize plantar nerves under ultrasound	Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)	40 minutes
Secondary	Patient satisfaction	Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)	At the end of surgery (2 hours maximum)
Secondary	Patient comfort during block performance	Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)	40 minutes
Secondary	Complication	Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.	Day 15 and Day 30 After Surgery