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临床试验/CTRI/2026/03/106741
CTRI/2026/03/106741尚未招募不适用

COMPARATIVE ANALYSIS OF ANAESTHETIC CHARACTERSTICS AND SAFETY OF INTRATHECAL 0.75% HYPERBARIC ROPIVACAINE AND 0.5% HYPERBARIC BUPIVACAINE IN PATIENTS UNDERGOING INFRA-UMBILICAL SURGERIES - A RANDOMIZED DOUBLE - BLIND STUDY

Sardar Patel Medical College Bikaner1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年4月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1

研究概览

简要总结

Regional anaesthesia plays a pivotal role in providing effective pain relief and facilitating early recovery in patients undergoing infra-umbilical surgeries.

Spinal Anaesthesia (Intrathecal Anaesthesia) is a widely employed form of central neuraxial blockade.It involves the injection of a local anaesthetic into the cerebrospinal fluid (CSF) present in the subarachnoid space, typically between the L3-L4 or L4-L5 intervertebral space. This leads to reversible blockade of nerve conduction, resulting in loss of sensation and muscle relaxation below the level of the block.

Spinal anaesthesia is often favoured over general anaesthesia for surgical procedures involving the lower abdomen and lower limbs, owing to its numerous advantages such as the simplicity of equipment, cost-effectiveness, provision of profound analgesia, satisfactory muscle relaxation, reduced intra operative blood loss and minimal metabolic disturbances.

Ropivacaine and Bupivacaine are two long-acting local anaesthetics widely used in spinal anaesthesia. Both agents are effective for producing adequate sensory and motor block.

Bupivcaine, introduced in 1956, is an amino acid local anaesthetic comprising a racemic mixture of S- and R-enantiomers. It has become a preferred agent for spinal anaesthesia due to its ability to achieve effective sensory and motor blockade.

Bupivacaine has been associated with several side effects including motor weakness, urinary retention and toxicity affecting the cardiovascular and central nervous system.

Ropivacaine is a newer long-acting amide local anaesthetic and the monohydrate of the hydrochloride salt of 1-propyl-2’,6’-pipecoloxylidide. It is the first clinically used pure      S(-) enantiomeric local anaesthetic.  It came into market in 1996. This contributes to its lower risk of cardiovascular and central nervous system toxicity as compared to bupivacaine.

Although numerous studies have evaluated the use of ropivacaine for local infiltration, epidural and peripheral nerve blocks. Clinical data regarding its characteristics following intrathecal administration remain limited.

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 1 and 2 BMI 18.5 TO 30 KG/M2 ELECTIVE INFRA UMBILICAL SUREGRY UNDER SPINAL ANAESTHESIA.

排除标准

  • KNOWN HYPERSENSITIVITY TO AMIDE TYPE LOCAL ANAESTHETICS ASA 3and ABOVE BLEEDING DISORDERS LOCAL INFECTION.

研究者

发起方
Sardar Patel Medical College Bikaner
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR MOHAMMED YUNUS KHILJI

Sardar Patel Medical College Bikaner Rajasthan India

研究点 (1)

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