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临床试验/CTRI/2024/02/063007
CTRI/2024/02/063007尚未招募1 期

A comparative study Of intrathecal (0.75%) Ropivacaine and (0.75%) Ropivacaine with Fentanyl in daycare perianal surgeries.

Dr ARUNKUMAR A BARASAKALE1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月3日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1.Time taken for ambulation without assistance.

研究概览

简要总结

Subarachnoid block (SAB) is most widely used regional anesthesia technique in the world. It is a reliable, quick, effective and safe technique with predictable benefits, and has been the procedure of choice for perianal surgeries unless contraindicated.  The changing trend of surgical practice from an inpatient to outpatient has urged us to use short duration acting local anesthetic.

An ideal anesthetic for spinal anesthesia in ambulatory

surgery should provide rapid onset, adequate potency, predictable duration, decreased neurotoxicity along with minimal systemic side effects.The evidence for transient neurological symptoms (TNS) associated with the short-acting spinal anesthetic lidocaine has led to the use of alternative drugs such as bupivacaine, levobupivacaine or ropivacaine. Ropivacaine is the pure S enantiomer of propivacaine and is a amide local anaesthetic which is associated with a lower grade of motor block, a shorter duration of action than bupivacaine and a reduced potential for CNS and cardiac toxicity, making it a possible alternative to lidocaine for shorter outpatient procedures.

The dose of local anesthetic  can be reduced by the addition of adjuvant like opioids and alpha 2 adrenergic agonists.

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.

We hypothesise that addition of fentanyl to ropivacaine as neuraxial adjuvant improves the quality of spinal block and prolongs postoperative analgesia without significantly prolonging the time for ambulation without assistance.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant 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

  • 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) Local site infections.
  • c) H/o hypersensitivity to study drugs.

结局指标

主要结局

1.Time taken for ambulation without assistance.

时间窗: 24 hours

次要结局

  • 1.Time to achieve T10 sensory block(2.Maximum height of sensory block)

研究者

发起方
Dr ARUNKUMAR A BARASAKALE
申办方类型
Other []

研究点 (1)

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