COMPARISON OF SPINAL ANAESTHESIA WITH LEVOBUPIVACAINE, ROPIVACAINE AND BUPIVACAINE FOR LSCS

Not yet recruiting

• Conditions: Sequelae of complication of pregnancy, childbirth, and the puerperium,

• Registration Number: CTRI/2023/05/053079
• Lead Sponsor: Dean Government Medical College and Hospital Aurangabad

Brief Summary

Hyperbaric bupivacaine is most common used drug in spinal anaesthesia. Levobupivacaine and ropivacaine are two amide local anaesthetic drugs developed in order to address the bupivacaine toxicity. This randomized prospective double-blind study will be conducted to compare the time to reach maximum sensory level, onset and duration of sensory & motor block, hemodynamic and adverse effects after SA with levobupivacaine and ropivacaine.

180 patients between 18 to 35 years, ASA grade II, weight 40-70 kg, BMI< 30 posted for elective LSCS under spinal anaesthesia will be randomly allocated using computer generated randomization list & sealed envelope technique into 3 groups with 60 patients in each group with allocation ratio 1:1:1. In Group L- inj Levobupivacaine 0.5 â„… (Heavy) 2cc, in Group R- inj Ropivacaine 0.75 â„… (Heavy) 2 cc & in Group B- inj Bupivacaine 0.5â„… (Heavy) 2 cc will be given for SA.

Time of onset of sensory Block, time of onset of motor Block, peak sensory level will be assessed by loss of pinprick sensation every 2 mins until the highest level is stabilized   hemodynamic and adverse effects will be noted.

Data analysis will be done by appropriate statistical method with statistical software SPSS Ver. 20. P value less than 0.05 will be taken as significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-06
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

1.Pregnant females undergoing elective LSCS surgery under spinal anaesthesia 2.ASA grade II 3.Age 18-35 years 4.Weight 40-70 kg 5.BMI< 30.

Exclusion Criteria

• 1.Patient refusal for procedure.
• 2.History of allergy to drugs, Infection on back.
• 3.Patient with Uncontrolled hypotension, cardiovascular disease, hepatic or renal disease, bronchospastic disease.
• 4.ASA Grade 3 or more.
• 5.Emergency surgeries.
• 6.Patients taking any psychotropic drugs, Seizure disorder, Coagulopathy, morbid obesity or any contraindication to SA.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to reach maximum sensory level of spinal anaesthesia	2, 4, 6, 8, 10, 15, 20, 25, 30 minutes after spinal anaesthesia

Secondary Outcome Measures

Name	Time	Method
The onset and duration of sensory & motor block Hemodynamic effects	Adverse effects

Trial Locations

Locations (1)

Government Medical College & Hospital, Aurangabad; 🇮🇳 Aurangabad, MAHARASHTRA, India

Government Medical College & Hospital, Aurangabad

🇮🇳Aurangabad, MAHARASHTRA, India

Dr Joshi S A

Principal investigator

9422777903

khadkesuchita@gmail.com