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

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ClinicalTrials.gov Identifier: NCT03504462
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

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.


Condition or disease Intervention/treatment Phase
Hallux Valgus and Bunion (Disorder) Morton Neuroma Metatarsal Fracture Ingrown Nail Foot Wound Foot Infection Procedure: Specific block of medial and lateral plantar nerves Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Specific Block of the Plantar Branches of the Tibial Nerve Under Ultrasound for Foot Surgery : A Monocentric Pilot Study
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : June 24, 2019

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  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


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504462


Contacts
Contact: Sébastien Bloc, MD (+33)662135682 agsb@mac.com

Locations
France
CMC Ambroise Paré Recruiting
Neuilly-sur-Seine, Ile-de-France, France, 92200
Contact: Cécile Naudin, PhD       recherche@clinique-a-pare.fr   
Principal Investigator: Sébastien Bloc, MD         
Sponsors and Collaborators
CMC Ambroise Paré
Investigators
Principal Investigator: Sébastien Bloc, MD CMC Ambroise Paré

Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03504462     History of Changes
Other Study ID Numbers: 2018/03
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CMC Ambroise Paré:
Foot surgery
Regional Anesthesia
Regional Analgesia
Ultrasound
Distal block
Plantar nerve block

Additional relevant MeSH terms:
Hallux Valgus
Neuroma
Morton Neuroma
Nails, Ingrown
Foot Deformities
Musculoskeletal Diseases
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Metatarsalgia
Foot Diseases
Joint Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Nail Diseases
Skin Diseases