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临床试验/NCT02458742
NCT02458742已完成不适用

Spinal Morphine (0.05 mg) Provides an Effective Pain Control in Patients Undergoing Transurethral Resection of Prostate Gland- a Randomized Double-blinded Control Trial

Mahidol University0 个研究点目标入组 80 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
主要终点
Numerical rating scale (0-10)

研究概览

简要总结

Pain after transurethral resection of prostate is considered mild to moderate severity from detrusor muscle spasm and traction from urinary catheter. Numerous pain relieve methods have been studied including spinal opioids, spinal anesthesia with local anesthetic and dexmedetomidine, periprostatic nerve blockade with bupivacaine and mixing of prilocaine with distilled water irrigation while undergoing a procedure. Most of patients having this procedure are in elderly period, thus many anesthetists avoided spinal morphine which may cause respiratory depressant effect postoperatively. Although previous studies showed effectiveness of spinal morphine 25-200 mcg, some patients suffered from neuraxial opioid side effects.

The aim of this study is to demonstrate efficacy of local anesthetic with intrathecal morphine 50 mcg providing pain relieve after transurethral resection of prostate compare to spinal anesthesia with sole local anesthetic.

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, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Age > or = 18 years old
  • Undergoing transurethral resection of prostate gland

排除标准

  • Contraindication for spinal anesthesia for any reasons eg. infection, bleeding disorder
  • Refuse spinal anesthesia
  • Allergic to study drugs
  • History of cerebrovascular disease or stroke

研究组 & 干预措施

Morphine

Experimental

0.5%Bupivacaine 2 ml with morphine 50 mcg for spinal anesthesia

干预措施: Morphine (Drug)

Placebo

Placebo Comparator

0.5%Bupivacaine 2 ml for spinal anesthesia

干预措施: Placebo (Drug)

结局指标

主要结局

Numerical rating scale (0-10)

时间窗: 24 hours postoperatively

Pain score rating by numerical rating scale in 24-hr postoperative

次要结局

  • Adverse effects(24 hours postoperatively)
  • Satisfaction score(24 hours postoperatively)
  • Requirement of rescue pain(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

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