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临床试验/CTRI/2024/04/065646
CTRI/2024/04/065646尚未招募2 期

A comparative study of intrathecal (0.75%) ropivacaine with fentanyl and intrathecal (0.75%) ropivacaine with morphine in day care perianal surgeries.

Dr Shirley Paulina1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare the duration of analgesia in each group.

研究概览

简要总结

Subarachnoid block is a popular anaesthesia procedure practiced worldwide. It is a standard procedure for lower abdominal, lower limb and perianal surgeries. It is a more reliable, quick procedure, applicable in emergency surgeries. An ideal anaesthetic for spinal anaesthesia in ambulatory surgery should provide rapid onset, adequate potency, predictable duration, decreased neurotoxicity along with minimal systemic side effects.

Ropivacaine has high pKa , low lipid solubility, it has great degree of sensory blockade and lesser duration of motor blockade compared to Bupivacaine. It also provides rapid sensorimotor dissociation. It is a favorable drug for day care surgeries. Adjuvants like Opioids when added to Ropivacaine have shown to prolong the duration analgesia after surgery.

Subarachnoid fentanyl is known to provide rapid onset of analgesia, improve surgical blockade quality and enhance the effect of small doses of subarachnoid local anaesthetic. Intrathecal morphine used as a ‘one-shot’ method provides several advantages as it is easy, cost-effective, and reliable, and technical failures are rare. The analgesic effects last for 20–48 h. Morphine results in cephalad spread, thereby increasing the area of analgesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • a) Patients aged between 18 to 60 years of age posted for elective perianal surgeries.
  • b) ASA grade I and II patient.

排除标准

  • a)Patients who has H/o coagulation and bleeding disorders.
  • b) Infection at the site of spinal anesthesia c) H/o hypersensitivity to study drugs.
  • d) Patients not giving consent.

结局指标

主要结局

To compare the duration of analgesia in each group.

时间窗: 24 hours

次要结局

  • 1.Time to achieve S1 sensory block(2.Degree of motor block)

研究者

发起方
Dr Shirley Paulina
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shirley Paulina

DR B R Ambedkar medical college and hospital Bengaluru

研究点 (1)

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