A COMPARATIVE STUDY OF INTRATHECAL ISOBARIC ROPIVACAINE 0.75% WITH FENTANYL VERSUS ISOBARIC 2 -CHLOROPROCAINE 1% WITH FENTANYL IN PATIENTS UNDERGOING LOWER SEGMENT CAESAREAN SECTION
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- •Onset of sensory blockade
Study Overview
Brief Summary
In this study, we will compare the efficacy ofintrathecal isobaric ropivacaine 0.75% (22.5mg) with fentanyl (25mcg) versusisobaric 2-chloroprocaine 1 %(30mg) with fentanyl (25mcg) in patientsundergoing lower segment caesarean section.
PRIMARY OBJECTIVE:
· Onset of sensory blockade
· Duration ofanalgesia.
SECONDARY OBJECTIVES:
· Highest level ofsensory blockade
· Duration of sensoryblockade.
· Onset of motorblockade.
· Duration of motorblockade.
· Quality of motorblock
· Two segment regression.
· Effect on hemodynamicparameters.
· Neonatal outcome.
· Complications likenausea, vomiting, pruritus, respiratory distress, sedation, bradycardia (<50bpm),hypotension (decrease in SBP>30% baseline or <100mm Hg
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Parturients posted for LSCS
- •Age between 18 – 40 years.
Exclusion Criteria
- •Age < 18 and > 40 years.
- •Patients refusal.
- •Patient sensitive / allergic to local anaesthetic agents.
- •Patients with peripheral sensorineural deficit.
- •Patients on anticoagulants.
- •Infection at the site of lumbar puncture.
Outcomes
Primary Outcomes
•Onset of sensory blockade
Time Frame: Time duration of the study is around 1 year
•Duration of analgesia.
Time Frame: Time duration of the study is around 1 year
Secondary Outcomes
- •Highest level of sensory blockade(•Duration of sensory blockade.)