EUCTR2016-003544-37-GB进行中（未招募）1 期
Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial (PLACEMENT) - PLACEMENT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The following patients are suitable for inclusion into the study:
- •patients aged 18 years or older
- •undergoing elective or emergency major lower limb amputations (BKA, or AKA) for complications of PVD
- •able to assess pain using a VRS
- •those with a life expectancy of greater than two weeks
- •(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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •The following patients are not suitable for inclusion into the study:
- •patients undergoing digital, metatarsal, tarsal amputation, disarticulation of the hip or hindquarter amputation
- •patients undergoing simultaneous bilateral amputations
- •patients undergoing through knee amputation (TKA)
- •patients who are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005)
- •vulnerable or protected adults
- •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.
- •pregnant females
- •patients expected to be managed in the intensive care unit (ICU) postoperatively and be sedated for more than 24 hours
- •patients undergoing a subsequent amputation who have already been enrolled to participate in the PLACEMENT trial.
- •Patients who met the inclusion criteria but who subsequently are not suitable for randomisation include:
- •patients where a planned major amputation was not performed (due to either anaesthetic or surgical difficulties)
- •patients where a major amputation was performed but the appropriate nerve was not identified
- •patients who, due to instability in the intra-operative period, require admission to the ICU postoperatively and are most likely to be sedated for more than 24 hours
- •patients who, due to instability in the intra-operative period, are not expected to survive more than two weeks
研究者
相似试验
进行中（未招募）
3 期
Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT)ISRCTN72547749Cardiff University650
进行中（未招募）
1 期
Comparison of different treatment modalities in peripheral nerve block catheter-based pain treatment after orthopaedic surgery.Postoperative pain, after orthopaedic surgery.MedDRA version: 20.0 Level: PT Classification code 10029173 Term: Nerve block System Organ Class: 10042613 - Surgical and medical proceduresEUCTR2017-002280-18-DKordsjællands Hospital Hillerød270
已完成
2 期
Perineural local anaesthetic catheter after major lower limb amputation feasibility trialMajor lower limb amputationCirculatory SystemISRCTN85710690Aneurin Bevan University Health Board50
进行中（未招募）
1 期
The use of a supraclavicular nerve catheter for local anesthetic block of the shoulder- an explorative study in healthy volunteers.MedDRA version: 19.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863EUCTR2016-002835-14-DKordsjællands Hospital Hillerød
已完成
不适用
Continuous administration of local anesthetic for pain after amputation above kneePain after amputation above kneeSigns and SymptomsISRCTN45530042Helsinki University Hospital (Finland)180