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临床试验/NCT03032458
NCT03032458已完成4 期

Efficacy of Pethidine, Ketorolac And Xylocaine Gel As Analgesics For Pain Control In Shockwave Lithotripsy Single Blinded Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2017年1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
已完成
入组人数
165
试验地点
1
主要终点
Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"

研究概览

简要总结

A randomised prospective trial comparing the efficacy of pethidine, Ketorolac, and Xylocaine gel as analgesics for pain control in shockwave lithotripsy.

详细描述

Pain perception during shockwave lithotripsy (SWL) is affected by patient-related factors like age, gender, and body habitus moreover, young female patients, anxious and depressed patients or thin patients experience more pain during SWL.

Several physical variables influencing treatment-related pain have been identified: the type of the shockwave source, size, and site of stone burden, peak pressure of the shockwaves, diameter of the focal zone, and size of the aperture of the shockwave source reflecting the area of shockwave entry at the skin.

Pain relief during SWL is vital, not only to maintain patient comfort and satisfaction, but also to facilitate stone imaging and targeting by reducing patients' movements during successive shock wave impacts. Reduced patient movement enables increase fragmentation efficiency and reduce the risk of procedure-related morbidity. So, a relaxed, cooperative patient during treatment is paramount in maintaining stone targeting for optimal fragmentation.

Across 21 centers in the United Kingdom (UK), 17 distinct analgesia regimens were reported in SWL analgesia practice.

In 2016 European Association of Urology (EUA) guidelines for SWL Pain control stated that pain control during SWL is necessary to limit pain induced movements and excessive respiratory excursions, However no recommendation for proper analgesia in contrast to clear recommendation for Pain relief in patients with an acute stone episode.

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
Single (Participant)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with renal and upper ureteral stones amenable to SWL.

排除标准

  • Allergy to pethidine.
  • Allergy to Ketorolac.
  • Allergy to Xylocaine gel.
  • American Society of Anesthesiologists score ≥ 3 (ASA III or more).
  • Pregnancy.
  • Patients with a pacemaker.
  • Bleeding diatheses.
  • Uncontrolled urinary tract infection (UTI).
  • Severe obesity which prevent targeting of the stone.
  • Body Mass IndexBMI (40 or more)
  • Arterial aneurysm in the vicinity of the stone.
  • Anatomical obstruction distal to the stone.

研究组 & 干预措施

Pethidine

Active Comparator

Pethidine 25 mg IV bolus (Pethidine hydrochloride 50mg ampule, Roche Pharmaceutical Company - Egypt)

干预措施: Pethidine (Drug)

Ketorolac

Active Comparator

Ketolac 30 mg (ketorolac, Amriya Pharmaceutical Industries - Egypt)

干预措施: Ketorolac (Drug)

Xylocaine Gel

Active Comparator

Xylocaine gel (lidocaine 2%, AstraZeneca Pharmaceutical Company - Egypt)

干预措施: Xylocaine Gel (Drug)

结局指标

主要结局

Pain control __ Outcome Measure by "pain assessment scales of The National Initiative on Pain Control™ (NIPC™)"

时间窗: 10 months

次要结局

  • Effect of anxiety on success of SWL __ Outcome Measure by "The Patient Health Questionnaire (PHQ-9)"(10 months)
  • Compare stone free rate __ Outcome Measure by "ultrasound and plain x-ray" 1 week after session. If no residual stone, NCCT scan.(1 year)
  • Effect of anxiety on success of SWL __ Outcome Measure by "Generalized Anxiety Disorder 7-item "(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Mansoura University

研究点 (1)

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