Clinical trial of the investigational medicinal product, local anaesthetic levo-bupivacaine in infants 3 - 6 months post natal age. - Ratifying dosage and duration of levo-bupivacaine infusion in infants.

Central Manchester University Hospitals NHS Foundation Trust0 个研究点目标入组 10 人开始时间: 2015年4月30日最近更新: 2019年6月30日

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•All infants aged between 3–6 months postnatal age, undergoing Bladder Exstrophy repair will be considered. But only those infants whose parents consent to a caudal-epidural block, as well as to this study will be included.
•This is a rare condition and we see 5-7 patients/year. Taking into account the exclusion criteria we expect to take 18 months - 2 years to include 10 patients in the study.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 10
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•1. Lack of consent.
•2. Known hypersensitivity to amide local anaesthetics.
•3. History of seizures or neurological disorders.
•4. Presence of blood-clotting disorders or blood dyscrasias.
•5. Local congenital abnormalities/infection that contraindicates regional anaesthetic technique.
•6. Technically difficult to administer the caudal - epidural block.

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