A study to compare spinal anesthesia in caesarean section when drug is given according to height and weight versus a fixed dose.

Not yet recruiting

Conditions: Encounter for cesarean delivery without indication,

Registration Number: CTRI/2022/04/042328

Lead Sponsor: Saveetha medical college hospital

Brief Summary: The preferred choice of anaesthesia for conducting emergency and elective caesarean section is spinal considering the various physiological changes in pregnancy. Hypotension still persists as a major problem during spinal anaesthesia.

Various strategies employed to prevent hypotension are preloading with intravenous fluid, leg elevation, prophylactic administration of vasopressors, using lower dose of local anaesthetic agents, use of additives like clonidine, opioids etc.

The dose of bupivacaine is reduced in obstetric patients due to increased sensitivity of neural tissue, alteration in CSF volume, weight gain and exaggerated lordosis. As a result of these factors which ultimately result in significant cephalad spread resulting in higher level of blockade causing maternal discomfort and hypotension.

The dose of bupivacaine for patients undergoing LSCS under spinal is around 12mg (12.78 mg for normal weight and 11.86 mg for obese population). Studies have proved that dose of bupivacaine based on height for spinal anaesthesia in LSCS patients is 0.06mg/cm.

The use of 8-10mg bupivacaine has been associated with lesser incidences of hypotension but greater intraoperative need for analgesia to dampen the pain.

This results in a wide range of dose of bupivacaine administered to these patients.

The purpose of this study is to analyze the characteristics of block achieved with height and weight adjusted dose of bupivacaine with fentanyl versus a fixed dosage of bupivacaine with fentanyl in elective caesarean section patients so as to find the optimum dose of drug required for adequate anaesthesia, which in turn will reduce the usage of vasopressors.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

Patient undergoing elective LSCS 2) Age 18-40 yrs 3) ASA II patients 4) Weight 50-90 kg 5) Height 140cm-180cm 6) Singleton pregnancy.

Exclusion Criteria

Emergency caesarean section 2) Patients refusing spinal anesthesia 3) Infection at the site of regional blockade 4) Bleeding diathesis 5) Hypersensitivity to the study drug 6) Allergy to local anaesthetics 7) Neurological diseases 8) Spinal deformities.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of heart rate and blood pressure between the fixed dose of bupivacaine and bupivacaine based on Hartens chart	Baseline, pre-spinal, post-spinal, 5mins, 15mins, 30mins, 60 mins, 120 mins, post anesthesia care unit

Secondary Outcome Measures

Name	Time	Method
Comparison of onset of sensory blockade in both the groups
comparison of motor regression time	every 15 minutes
comparison of sensory regression	every 15 minutes
quality of block assessed by surgeon	after surgery
quality of Intraoperative analgesia assessed by patient	once after surgery
APGAR score of baby	after baby delivery and at 5 minutes after delivery
complications	every 10 minutes

Trial Locations

Locations (1): Saveetha Medical College and Hospital
🇮🇳
Chennai, TAMIL NADU, India
Saveetha Medical College and Hospital
🇮🇳Chennai, TAMIL NADU, India
rohit kamal
Principal investigator
9003133672
rohankamal@gmail.com