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 : December 30, 2019
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|
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)|
|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, 2020|
|Estimated Study Completion Date :||June 24, 2020|
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.
- 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
- 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
- Ability to recognize plantar nerves under ultrasound [ Time Frame: 40 minutes ]Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
- 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)
- Patient comfort during block performance [ Time Frame: 40 minutes ]Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
- 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.
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
|Contact: Sébastien Bloc, MD||(+33)email@example.com|
|CMC Ambroise Paré||Recruiting|
|Neuilly-sur-Seine, Ile-de-France, France, 92200|
|Contact: Cécile Naudin, PhD firstname.lastname@example.org|
|Principal Investigator: Sébastien Bloc, MD|
|Principal Investigator:||Sébastien Bloc, MD||CMC Ambroise Paré|