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临床试验/NCT02198027
NCT02198027Unknown4 期

Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control

Indus Hospital and Health Network1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
68
试验地点
1
主要终点
Mean time for first demand of rescue analgesic

研究概览

简要总结

Patients may feel significant pain at the surgery site after they wake up from the surgery. Usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. Some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. If investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 years of age
  • Single PCNL track

排除标准

  • Spinal Disc Prolapse
  • Any previous renal surgery
  • Complication secondary to PCNL
  • Hydrothorax that requires intervention
  • Pneumothorax
  • Massive hemorrhage that requires more than 1 U transfusion
  • Conversion to open procedure.

研究组 & 干预措施

Bupivacaine infiltration

Experimental

10 ml of 0.25 % Bupivacaine

干预措施: Bupivacaine (Drug)

Normal saline infiltration

Placebo Comparator

10 ml of normal saline

干预措施: Normal saline infiltration (Other)

结局指标

主要结局

Mean time for first demand of rescue analgesic

时间窗: Release of the patient from the hospital or 24 hours (whichever comes first)

Mean time for first demand defined as the difference in time between the first time rescue medications is given to patient in post-operatively and the time the infiltration took place intra-operatively

次要结局

未报告次要终点

研究者

发起方
Indus Hospital and Health Network
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeeshan Arshad

Resident, Urology

Indus Hospital and Health Network

研究点 (1)

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