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Clinical Trials/CTRI/2025/04/085023
CTRI/2025/04/085023Not yet recruitingPhase 2

Prospective Randomized double blind comparitive study between the efficacy of intrathecal 0.5 percent Bupivacaine heavy vs isobaric in elective lscs.

dy patil school of medicine and hospital nerul navi mumbai1 site in 1 country48 target enrollmentStarted: May 1, 2025Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
48
Locations
1
Primary Endpoint
To compare the anaesthetic properties of isobaric and hyperbaric

Study Overview

Brief Summary

Elective lower segment cesarian section is a commonly performed surgical procedure which requires anaesthesia. Most common mode of anaesthesia used is spinal anaesthesia . The drug commonly used to give spinal anaesthesia in such patients is injection bupivacaine 0.5 percent hyperbaric. This study aims to compare the anaesthetic properties and haemodynamic changes caused by the aforementioned drug to isobaric injection bupivacaine 0.5 and its anaesthetic properties and haemodynamic changes.

Inclusion criteria includes patients undergoing elective cesarian section between the ages of 20 and 40. ASA 2. Height more than 150 cms and gestational age of greater than 35 weeks.

Similarly exclusion criteria involves patients undergoing emergency lower section cesarean section , contraindication or allergy to the above used drugs, contraindication to spinal anaesthesia, patient refusal.

The study will be conducted in dy patil school of medicine and hospital, nerul, navi mumbai. Over a period of 2 years.

The study method is randomised control trial double blind.

Sample size is 48.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • 1 All patients giving consent undergoing elective lscs 2 ASA grade 2 3 patients coming for elective c-section with gestational age og greater than 35 weeks 4 height more than 150 cms.

Exclusion Criteria

  • Patients undergoing emergency C-SECTIONS 1 Patients known or suspected to have allergy for study drugs.
  • 2 Patient refusal 3 Patients with contraindications to spinal anaesthesia.

Outcomes

Primary Outcomes

To compare the anaesthetic properties of isobaric and hyperbaric

Time Frame: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins

bupivacaine in spinal anaesthesia, which includes the time of onset of sensory

Time Frame: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins

and motor block and duration of block obtained (both sensory and motor)

Time Frame: at base line,2 mins,4 mins, 6 mins, 8 mins, 15 mins, 20 mins, 25 mins, 30 mins, 40 mins, 50 mins, 60 mins

Secondary Outcomes

  • To compare the effects of both the drugs on haemodynamic(parameters which include heart rate & blood pressure & side effects.)

Investigators

Sponsor
dy patil school of medicine and hospital nerul navi mumbai
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr kaushik dandanak

D.Y Patil school of medicine

Study Sites (1)

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