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临床试验/NCT02121951
NCT02121951撤回4 期

Quadratus Lumborum Block Versus Local Anesthetic Infiltration Combined With Monitored Anesthesia Care for Percutaneous Nephrostomy

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
Analgesia

研究概览

简要总结

Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone position.

详细描述

Quadratus Lumborum block is a novel technique in which extension into the thoracic paravertebral space may occur. QL block would seem to be able to alleviate both somatic and visceral pain so it's expected to decrease the need for systemic sedation\analgesia to a minimum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA grade III and IV patients,
  • Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy

排除标准

  • Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm
  • Untreated urinary tract infection;
  • Pre-operative haemoglobin <10 gm/dl,
  • Severely co morbid patients
  • Non-dilated renal collecting system
  • Patient refusal to consent for the procedure.

研究组 & 干预措施

Local Anesthetic infiltration and MAC

Active Comparator
  • Local Anesthetic infiltration with 1% lignocaine
  • MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml

干预措施: Local Anesthetic infiltration (Procedure)

Local Anesthetic infiltration and MAC

Active Comparator
  • Local Anesthetic infiltration with 1% lignocaine
  • MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml

干预措施: MAC (Drug)

Quadratus Lumborum block and MAC

Experimental
  • QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine
  • MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml

干预措施: Quadratus Lumborum block (Procedure)

Quadratus Lumborum block and MAC

Experimental
  • QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine
  • MAC with IV Midazolam Img\ml and Fentanyl 10 mic\ml

干预措施: MAC (Drug)

结局指标

主要结局

Analgesia

时间窗: 4 hours

Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.

次要结局

  • Respiratory Depression(4 hours)
  • Sedation(4 hours)
  • Cardiovascular stability(4 hours)
  • Patient Satisfaction(48 hours)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada M N Bashandy

Dr

National Cancer Institute, Egypt

研究点 (1)

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