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Clinical Trials/CTRI/2023/10/059159
CTRI/2023/10/059159CompletedUnknown

A Comparative study of 0.5% hyperbaric Levobupivacaine and 0.5% hyperbaric Bupivacaine for spinal anaesthesia in elective lower segment casearean sections

Dr SINGIDI PRASANTHI1 site in 1 country60 target enrollmentStarted: June 11, 2023Last updated:

Trial Snapshot

Phase
Unknown
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To compare various effects of intrathecal 0.5% Hyperbaric Levobupivacaine & 0.5%hyperbaric Bupivacaine in elective lower segment casearean sections

Study Overview

Brief Summary

Spinal anaesthesia is the most common anesthesia used in elective and emergency lower segment casearean sections.Hyperbaric solutions are generally preferred in subarachnoid block because they provide sufficient block and do not cause high block levels commonly

Bupivacaine has R and S enantiomers they have different affinity on sodium and potassium channels.S enantiomers are relatively less cardiotoxic and neurotoxic.In recent studies Levobupivacaine as safer alternative for regional anesthesia than racemic Bupivacaine.

Hence we aim to study hyperbaric Levobupivacaine 0.5%, and Hyperbaric Bupivacaine 0.5%, with respect to hemodynamic changes,block characteristics, postoperative complications

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 1.Patients undergoing elective lower segment casearean sections from 18-40years age 2.ASA physical status II.

Exclusion Criteria

  • 1.Patients with ASA physical status III,IV 2.Patients having any contraindications to spinal anaesthesia 3.Patients with history of allergy to local anaesthetic.

Outcomes

Primary Outcomes

To compare various effects of intrathecal 0.5% Hyperbaric Levobupivacaine & 0.5%hyperbaric Bupivacaine in elective lower segment casearean sections

Time Frame: At Oth minute immediately & then 3 6 9 15 20 25 30 45 60 75 90

1.Hemodynamic changes

Time Frame: At Oth minute immediately & then 3 6 9 15 20 25 30 45 60 75 90

Secondary Outcomes

  • Sensory & motor blockade characteristics(At 5minutes)

Investigators

Sponsor
Dr SINGIDI PRASANTHI
Sponsor Class
Other [self]

Study Sites (1)

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