Intrathecal hyperbaric bupivacaine versus hyperbaric ropivacaine in spinal anaesthesia in caesarean sections: a randomised control trial in a teaching hospital in northeast India.

Phase 3

Not yet recruiting

• Conditions: Other complications of anesthesiaduring pregnancy,

• Registration Number: CTRI/2024/05/067399
• Lead Sponsor: Neon

Brief Summary

Group B of inj bupivacaine 0.5% hyperbaric solution 2.4 cc will be compared with Group R inj ropivacaine 0.75%  2.4 cc hyperbaric solution.

Each group 33 each elective caesarean cases will be taken as per inclusion and exclusion criteria.

The injection will be given using 25G quinckes spinal needle at L3-4, L4-5 level, sub arachnoid space in sitting position.

Onset of sensory, motor blockade, duration regression of sensory (T10)and motor (bromage 0), time of use of rescue analgesia,

Intra op nd post op complicationa like nausea, vomiting, bradycardia, hypotension, respiratory depression shivering to be compared

Haemodynamics intra op and post op till 12 hours

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-05-14
• Study Start: 2024-05-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 66

Inclusion Criteria

• i.All patients who will be registered for elective caesarean delivery and belonging to ASA (American Society of Anesthesiologists) grade I & II only.
• ii.Patients between 145to 165 cms of height.
• iii.Patients who will give valid informed written consent.
• iv.Pregnancy over 37 weeks and less than 42 weeks.
• v.Patient with weight of 45-95kgs.

Exclusion Criteria

• i.Patient with abnormalities and problems in the embryo.
• ii.Patient with indication of an emergency caesarean section.
• iii.Patients having history of hypersensitivity to anesthetic agents.
• iv.Infection at the subarachnoid block injection site.
• v.Pre-term and post term delivery.
• vi.ASA class higher than II.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the onset of action, duration of sensory and motor block, and duration of effective analgesia induced by intrathecal hyperbaric ropivacaine and hyperbaric bupivacaine in patients undergoing elective caesarean section.	0,3,6,9,12,15,20,30,45,60,90,120,150,180,240,300,360,480,600,720 hours

Secondary Outcome Measures

Name	Time	Method
1.To compare the haemodynamic variables in two groups during the intra operative & post operative period for 12 hours.	2.To evaluate & compare the adverse effects intra-operatively & post-operatively in the two groups.

Trial Locations

Locations (1)

Agartala Government Medical College & Govind Ballav Pant hospital; 🇮🇳 Tripura, TRIPURA, India

Agartala Government Medical College & Govind Ballav Pant hospital

🇮🇳Tripura, TRIPURA, India

Dr Sneha Chakraborty

Principal investigator

7085901835

snehachakraborty6@gmail.com