ISRCTN72547749进行中（未招募）3 期
Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial (PLACEMENT)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 02/07/2024:
- •1. Aged 18 years or older
- •2. Undergoing elective or emergency MLLA (BKA, TKA, or AKA) for complications of PAD, diabetes, or acute or chronic infection
- •3. Able to assess pain using NRS
- •4. Life expectancy of greater than two weeks
- •5. (For people of childbearing potential) Willing to undergo a preoperative pregnancy test and agree to either use a highly effective method of contraception or abstain from sexual intercourse for 7 days after MLLA.
- •6. (For male participants with female sexual partners who are considered to be of childbearing potential)* Willing to agree to use a condom or abstain from sexual intercourse for seven days after MLLA
- •Previous participant inclusion criteria:
- •1. Aged 18 years or older
- •2. Undergoing elective or emergency MLLA (BKA, TKA, or AKA) for complications of PAD and/or diabetes
- •3. Able to assess pain using NRS
- •4. Life expectancy of greater than two weeks
- •5. (For people of childbearing potential) Willing to undergo a preoperative pregnancy test and agree to either use a highly effective method of contraception or abstain from sexual intercourse for 7 days after MLLA.
- •6. (For male participants with female sexual partners who are considered to be of childbearing potential)* Willing to agree to use a condom or abstain from sexual intercourse for seven days after MLLA
排除标准
- •Current participant exclusion criteria as of 02/07/2024:
- •1. Undergoing MLLA for trauma or cancer
- •2. Undergoing digital, metatarsal, tarsal amputation, disarticulation of the hip or hindquarter amputation
- •3. Undergoing simultaneous bilateral amputations
- •4. Undergoing MLLA revision (excluding previous guillotine amputation)
- •5. Allergy or intolerance to the PNC or local anaesthetic agents, or chronically taking class 1B anti-arrhythmic agents or local anaesthetic agents, for example in the form of transdermal patches.
- •6. Expected to be sedated for more than 24 hours postoperatively
- •7. Unable to provide consent due to incapacity (as defined by the Mental Capacity Act 2005)
- •8. Vulnerable or protected adults.
- •9. People who are currently pregnant or breastfeeding
- •10. Previously enrolled in PLACEMENT (excluding PLACEMENT feasibility trial) for a prior MLLA
- •Previous participant exclusion criteria:
- •1. Undergoing MLLA for trauma or cancer
- •2. Undergoing digital, metatarsal, tarsal amputation, disarticulation of the hip or hindquarter amputation
- •3. Undergoing simultaneous bilateral amputations
- •4. Undergoing MLLA revision
- •5. Allergy or intolerance to the PNC or local anaesthetic agents, or chronically taking class 1B anti-arrhythmic agents or local anaesthetic agents, for example in the form of transdermal patches.
- •6. Expected to be sedated for more than 24 hours postoperatively
- •7. Unable to provide consent due to incapacity (as defined by the Mental Capacity Act 2005)
- •8. Vulnerable or protected adults.
- •9. People who are currently pregnant or breastfeeding
- •10. Previously enrolled in PLACEMENT (excluding PLACEMENT feasibility trial) for a prior MLLA
研究者
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