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

June 26, 2020 updated by: CMC Ambroise Paré

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
40 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
40 minutes
Ability to recognize plantar nerves under ultrasound
Time Frame: 40 minutes
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
40 minutes
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)
At the end of surgery (2 hours maximum)
Patient comfort during block performance
Time Frame: 40 minutes
Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
40 minutes
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.
Day 15 and Day 30 After Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CMC Ambroise Paré

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sébastien Bloc, MD, CMC Ambroise Paré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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