Specific Block of the Plantar Branches of the Tibial Nerve Under Ultrasound for Foot Surgery : A Monocentric Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Feasibility of a specific block of the lateral and medial plantar nerves
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing a foot surgery
- •Consent for participation
- •Affiliation to the french social security system
排除标准
- •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
研究组 & 干预措施
Distal tibial nerve block
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
干预措施: Specific block of medial and lateral plantar nerves (Procedure)
结局指标
主要结局
Feasibility of a specific block of the lateral and medial plantar nerves
时间窗: 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
次要结局
- Complication(Day 15 and Day 30 After Surgery)
- Ability to recognize plantar nerves under ultrasound(40 minutes)
- Patient satisfaction(At the end of surgery (2 hours maximum))
- Feasibility of the foot surgery with a specific block of the lateral and medial plantar nerves(40 minutes)
- Patient comfort during block performance(40 minutes)