Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery (DISTIB)
Primary Purpose
Hallux Valgus and Bunion (Disorder), Morton Neuroma, Metatarsal Fracture
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Specific block of medial and lateral plantar nerves
Sponsored by
About this trial
This is an interventional other trial for Hallux Valgus and Bunion (Disorder) focused on measuring Foot surgery, Regional Anesthesia, Regional Analgesia, Ultrasound, Distal block, Plantar nerve block
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
Sites / Locations
- CMC Ambroise Paré
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Distal tibial nerve block
Arm Description
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Ability to recognize plantar nerves under ultrasound
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
Patient satisfaction
Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)
Patient comfort during block performance
Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
Complication
Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03504462
Brief Title
Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery
Acronym
DISTIB
Official Title
Specific Block of the Plantar Branches of the Tibial Nerve Under Ultrasound for Foot Surgery : A Monocentric Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
October 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Distal tibial nerve block
Arm Type
Experimental
Arm Description
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
Intervention Type
Procedure
Intervention Name(s)
Specific block of medial and lateral plantar nerves
Intervention Description
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 Measure Information:
Title
Feasibility of a specific block of the lateral and medial plantar nerves
Description
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
Time Frame
40 minutes
Secondary Outcome Measure Information:
Title
Feasibility of the foot surgery with a specific block of the lateral and medial plantar nerves
Description
Usage (or not) of an additional anesthetic procedure to perform the surgery
Time Frame
40 minutes
Title
Ability to recognize plantar nerves under ultrasound
Description
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
Time Frame
40 minutes
Title
Patient satisfaction
Description
Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)
Time Frame
At the end of surgery (2 hours maximum)
Title
Patient comfort during block performance
Description
Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
Time Frame
40 minutes
Title
Complication
Description
Questionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.
Time Frame
Day 15 and Day 30 After Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Bloc, MD
Organizational Affiliation
CMC Ambroise Paré
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMC Ambroise Paré
City
Neuilly-sur-Seine
State/Province
Ile-de-France
ZIP/Postal Code
92200
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery
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