Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foo… (NCT03504462) | Clinical Trial Compass
CompletedNot Applicable
Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery
France27 participantsStarted 2018-06-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a nerve block that specifically numbs the front of the foot while keeping the heel sensitive — is that kind of targeted anesthesia something that could be used for my procedure, and what are the advantages over numbing the whole foot?
2Since this study has already been completed, has my surgical team seen or used its findings, and do they think the technique is reliable enough to use in practice for conditions like mine?
3The trial looked at patients with a range of forefoot problems including hallux valgus, Morton's neuroma, and ingrown nails — does my specific condition match the types of cases where this block was tested and shown to be workable?
4What are the risks of this type of targeted nerve block compared to more standard anesthesia approaches for foot surgery, especially if the block doesn't work as planned during the procedure?
5If this selective nerve block technique isn't yet available or appropriate for me, what anesthesia options would you recommend for my foot surgery, and how do those compare in terms of recovery and sensation after the procedure?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves