Prospective, comparative, observational, single centre, pilot study to compare regression of sensory block of 0.75 % ropivacaine heavy with 0.5% bupivacaine heavy after subarachnoid block in pregnant patients coming for caesarean section.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To compare the level of sensory blockade between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy and To assess sensory level regression
Study Overview
Brief Summary
This study aims to compare the sensory and motor blockade regression following subarachnoid block (SAB) using 0.75% ropivacaine heavy versus 0.5% bupivacaine heavy in post-Caesarean section patients. The primary objective is to evaluate sensory block regression after SAB between the two anaesthetic agents. Secondary objectives include comparing sensory blockade levels at 90 seconds, 30 minutes, and 40 minutes post-SAB, as well as blood pressure and heart rate changes at 90 seconds and 5 minutes after SAB. Additionally, the level of motor blockade at 40 minutes post-SAB will be assessed. The study will include 24 participants aged 18-35, ASA status I and II, with uncomplicated singleton pregnancies, excluding those with comorbidities or contraindications to spinal anaesthesia. Data parameters include demographic details, sensory and motor blockade levels, blood pressure, and pulse rate at specified time intervals. The study will be conducted for over 1 year, with participants randomised into two groups: Group A (bupivacaine) and Group B (ropivacaine). The Primary Endpoints is to compare the level of sensory blockade between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy at: 90 seconds, 30 minutes, and 40 minutes post subarachnoid block also to assess sensory level regression at 30 minutes and 40 minutes after subarachnoid block. Secondary Endpoints of the study is to compare the percentage fall in blood pressure at 90 seconds and 5 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy.To compare the percentage change in heart rate at: 90 seconds and 5 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy. To compare the level of motor blockade at 40 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 35.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Parturient age group: 18-
- •ASA status: I and II.
- •Uncomplicated singleton pregnancy.
Exclusion Criteria
- •Patients unwilling to participate in the study.
- •ASA statues: greater than II.
- •Parturients with comorbidities like pregnancy induced hypertension and cardiovascular diseases.
- •Patients with altered consciousness, significant neurological, psychiatric, neuromuscular, cardiovascular diseases.
- •Morbid obesity [Body mass index (BMI)greater than 40 kg/m2] Obstetrical complications like Antepartum Haemorrhage, Pregnancy induced hypertension, raised intracranial pressure.
- •Contraindications to spinal anaesthesia like deformities of spine, Neurological disorders, Skin infections.
Outcomes
Primary Outcomes
To compare the level of sensory blockade between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy and To assess sensory level regression
Time Frame: Post administration of subarachnoid block: At 90 seconds, | 30 minutes, and | 40 minutes
Secondary Outcomes
- 1)To compare the percentage fall in blood pressure 2)To compare the percentage change in heart rate 3)To compare the level of motor blockade at 40 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy(1) To compare the percentage fall in blood pressure at:)
Investigators
Dr Shilpa Tiwaskar
Bhaktivedanta Hospital and Research Institute