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临床试验/CTRI/2024/06/069447
CTRI/2024/06/069447尚未招募3 期

A comparative study of Magnesium Sulphate versus Dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing lower abdominal surgeries

Jekha Mary Babu1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
A comparative study of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patient undergoing lower abdominal surgeries

研究概览

简要总结

It is a prospective, comparative, randomized, double blinded study to compare magnesium sulphate versus dexamethasone as an adjuvant to 0.25% bupivacaine in ultrasound-guided transversus abdominis plane block in patients undergoing lower abdominal surgeries. the parameters that will be assessed include quality of block, duration of block, timely post operative pain scores, time to rescue analgesia and total number of analgesics given in 24 hours

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, 2)Ages between 18 and 65 years, 3) Patients undergoing lower abdominal surgeries under spinal anaesthesia, 4) Hemodynamically stable patients with all routine investigations within normal limits without any other co-morbidities, 5)Patients who are not on any cardiac related drugs, 6) Availability of written informed consent from concerned patient.

排除标准

  • Patients not willing to participate in this study, 2)Patients with ASA physical status III and above physical status, 3)Patients less than 18 years and above 65 years of age, 4)Patients with uncontrolled systemic disorders like neurological, cardiac, metabolic, renal, pulmonary disorders, hepatic disease with coagulation abnormalities etc, 5)Patients on calcium channel blocker, 6)Patients having local infection at the site where needle for block was to be inserted, 7)Patients with contraindication for spinal anaesthesia, 8)Patients with bleeding or coagulation disorders, 9)Patients with known allergies to the study drugs, 10)Patients with weight less than 40 kgs and height less than 140 cms.

结局指标

主要结局

A comparative study of magnesium sulphate versus dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patient undergoing lower abdominal surgeries

时间窗: After administration of the block, pain scores will be assessed in both the groups in less than 5 minutes after giving block, after 2 hours, after 4 hours, after 6 hours, after 12 hours, after 16 hours, after 20 hours, and after 24 hours will be assessed

次要结局

  • A comparative study of magnesium sulphate & dexamethasone as an adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block in patient undergoing lower abdominal surgeries(Duration of analgesia will be assessed post giving block after surgery & time to rescue analgesia will be assessed)

研究者

发起方
Jekha Mary Babu
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Jekha Mary Babu

Dr. D. Y. Patil Medical College, Hospital and Research Centre

研究点 (1)

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