A Clinical to compare the effects of two drugs hyperbaric Bupivacaine and hyperbaric Ropivacaine in caesarean section under Spinal Anaesthesia.

Not yet recruiting

• Conditions: ICD-10-CM 082; Obstetrics,

• Registration Number: CTRI/2023/03/051045
• Lead Sponsor: Dr Millo Tama

Brief Summary

A major problem with Spinal Anaesthesia is that the use of local anaesthetics has ocassionally associated with adverse cardiac and neurotoxic side effects requiring early intervention in the early intraoperative period. The study will be prospective randomised double blinded study to asses and compare the effects of intrathecal administration of low dose 0.5% (2ml) hyperbaric bupivacaine versus 0.5% (2ml) hyperbaric ropivacaine in parturients undergoing LSCS under subarachnoid block..

A total of 60 parturient will be selected for the study and divided into two groups of 30 patients each like Group A (n=30) and Group B (n=30). According to a computer generated randomised table,patients in group A will be administered 2 ml of 0.5% bupivacaine heavy and group B will be administered 2 ml of 0.5% ropivacaine heavy in the subarachnoid space L3-L4.The block characteristic alongwith regression of the blockade,side effects (if any) and the haemodynamic changes will be observed,assesed and recorded by blind investigator using the VAS,Modified Bromage Scale. The data obtained will be collected and analysed using student ’t’ test for continous data and Chi square test forcategorical data as and where appropriate.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-24
• Study Start: 2023-03-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

ASA I or ASA II term Pregnant woman.

Exclusion Criteria

a.History of allergy to study drugs b.Bleeding disorder-platelet count <50,000/micro litre, prothrombin time>14 sec International normalised ratio(INR)->1.5 c.Local site infection d.Cardiac, respiratory diseases and kidney disorder, neurological deficit e.Spinal deformity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The block characteristics	outcome will be assesed after the administration of local anaesthetic at predetermined interval and data will be assesed at the end of the year.
2.regression of the blockade	outcome will be assesed after the administration of local anaesthetic at predetermined interval and data will be assesed at the end of the year.
3.side effects (if any)	outcome will be assesed after the administration of local anaesthetic at predetermined interval and data will be assesed at the end of the year.
4.hemodynamic changes	outcome will be assesed after the administration of local anaesthetic at predetermined interval and data will be assesed at the end of the year.

Secondary Outcome Measures

Name	Time	Method
1.BP,PR,	2.Onset sensory block 10

Trial Locations

Locations (1)

Regional Institute Of Medical Sciences,Imphal,Manipur; 🇮🇳 West, MANIPUR, India

Regional Institute Of Medical Sciences,Imphal,Manipur

🇮🇳West, MANIPUR, India

Dr Millo Tama

Principal investigator

8974354454

mitma1454@gmail.com