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临床试验/CTRI/2024/06/069037
CTRI/2024/06/069037已完成4 期

To Compare the Efficacy Of Diclofenac Patch vs Ketoprofen Patch As Post-operative Analgesia And Effect On Serum Creatinine In Patients Undergoing Percutaneous Nephrolithotomy (PCNL)

Vaibhavi Singh1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年6月26日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
To compare the Efficacy of Diclofenac patch vs Ketoprofen patch- As Post-op

研究概览

简要总结

It is a Prospective, randomized, double blinded study to  compare the Efficacy of Diclofenac patch vs Ketoprofen patch- As Post-op Analgesia and effect on serum creatinine in Patients Undergoing PCNL. Post op monitoring of VAS scoring will be recorded at rest, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours postoperatively. Post operatively after 24 hours serum creatinine will be repeated

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I or II fit patients.
  • Patients aged between 18 and 60 years of age.
  • Patients undergoing surgeries under spinal anesthesia.
  • Hemodynamically stable patients with all routine investigations within normal limits and without any comorbidities.
  • Written informed consent from the concerned patient.

排除标准

  • Patients who are not willing to participate in the study.
  • Patients with ASA grade III and above physical status.
  • Patients who are aged less than 18 and more than 60 years of age.
  • Patients who are posted for emergency procedures.
  • Patients with known allergy to the study drugs.
  • Patients who are obese.
  • Patients who have psychiatric, coagulopathies, neurological, neuromuscular, or cardiovascular disease or impairment of hepatic or renal function.
  • Patients with coagulopathies and contraindication to SA.

结局指标

主要结局

To compare the Efficacy of Diclofenac patch vs Ketoprofen patch- As Post-op

时间窗: To assess the VAS score at 0,4,8,12,16, 24 and 48 hours Post operatively

Analgesia and effect on serum creatinine in Patients Undergoing PCNL.

时间窗: To assess the VAS score at 0,4,8,12,16, 24 and 48 hours Post operatively

次要结局

  • To compare the Efficacy of Diclofenac patch vs Ketoprofen patch on serum creatinine in Patients Undergoing PCNL.(Post operatively after 24 hours serum creatinine will be repeated.)

研究者

发起方
Vaibhavi Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vaibhavi Singh

Dr. D. Y. Patil Medical College, Hospital And Research Centre, Pimpri, Pune

研究点 (1)

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