ISRCTN85710690已完成2 期
Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial: a phase II randomised controlled feasibility study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29284534 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31719071 results (added 04/12/2019) 2024 Other publications in https://doi.org/10.1080/09638288.2024.2329747 Qualitative study (added 17/04/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients aged 18 years or older
- •2. Undergoing elective or emergency major lower limb amputations (BKA, or AKA) for complications of PVD
- •3. Able to assess pain using a VRS
- •4. Those with a life expectancy of greater than two weeks
- •5. (For women of childbearing potential) willing to undergo a pregnancy test before the trial and agree to either use a highly effective method of contraception or abstain from sexual intercourse until at least seven days after their amputation
排除标准
- •1. Patients undergoing digital, metatarsal, tarsal amputation, disarticulation of the hip or hindquarter amputation
- •2. Patients undergoing simultaneous bilateral amputations
- •3. Patients undergoing through knee amputation (TKA)
- •4. Patients who are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005)
- •5. Vulnerable or protected adults
- •6. Patients with an allergy or intolerance to any of the substances in the PNC, or local anaesthetic agents, or chronically taking class IB anti-arrhythmic agents or local anaesthetic agents, for example in the form of transdermal patches.
- •7. Pregnant females
- •8. Patients expected to be managed in the intensive care unit (ICU) postoperatively and be sedated for more than 24 hours
- •9. Patients undergoing a subsequent amputation who have already been enrolled to participate in the PLACEMENT trial
研究者
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