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临床试验/CTRI/2025/03/082915
CTRI/2025/03/082915尚未招募4 期

A Comparitive Study Of Dexmeditomidate Versus Fentanyl As An Additive To Bupivacaine In Ultrasound Guided Transverse Abdominis Plane Block For Patients Undergoing Lower Abdominal Surgeries

DrSAKSHI GUPTA1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年1月8日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided

研究概览

简要总结

It is a prospective, randomized,doube blinded comparative study to to compare dexmedetomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided transverse abdominis plane block in patients undergoing lower abdominal surgeries.

Parameters that will be compared will be the duration of the analgesia and the post operative VAS scores and time to rescue analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA grade I or II fit patients.
  • Ages between 18 and 65 years
  • Patients undergoing lower abdominal surgeries .
  • Haemodynamically stable patients with all routine investigations within normal limits without any other co-morbidities.
  • Patients who are not on any cardiac related drugs.
  • Availability of written informed consent from concerned patient.

排除标准

  • Patients not willing to participate in this study.
  • Patients with ASA physical status III and above physical status.
  • Patients less than 18 years and above 65 years of age.
  • Patients with uncontrolled systemic disorders like neurological, cardiac, metabolic, renal, pulmonary disorders, hepatic disease with coagulation abnormalities etc.
  • Patients having local infection at the site where needle for block was to be inserted
  • Patients with bleeding or coagulation disorders.
  • Patients with known allergies to the study drugs.

结局指标

主要结局

To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided

时间窗: After administration of the block, comparison | between the two groups of onset and duration of | sensory and motor blockade, duration ofanalgesia and time to rescue to analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and | 10 mins after surgery.

transverse abdominis plane block in patients undergoing lower abdominal surgeries.

时间窗: After administration of the block, comparison | between the two groups of onset and duration of | sensory and motor blockade, duration ofanalgesia and time to rescue to analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and | 10 mins after surgery.

次要结局

  • To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided(transverse abdominis plane block in patients undergoing lower abdominal surgeries.)

研究者

发起方
DrSAKSHI GUPTA
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sakshi Gupta

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

研究点 (1)

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