CTRI Number |
CTRI/2022/04/042328 [Registered on: 29/04/2022] Trial Registered Prospectively |
Last Modified On: |
21/04/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A study to compare spinal anesthesia in caesarean section when drug is given according to height and weight versus a fixed dose. |
Scientific Title of Study
|
Comparison of spinal block characteristics
between height and weight based dosage versus fixed dosage of intrathecal bupivacaine for elective caesarean section
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rohit Kamal |
Designation |
Post Graduate student |
Affiliation |
Saveetha Medical College and Hospital |
Address |
Department of Anaesthesia, Hospital building Second floor, near OT complex, Saveetha Medical College, Thandalam, Chennai 602105
Kancheepuram TAMIL NADU 602105 India |
Phone |
9003133672 |
Fax |
|
Email |
rohankamal@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Gunasekaran Kalliyaperumal |
Designation |
Professor |
Affiliation |
Saveetha Medical College and Hospital |
Address |
Anaesthesia department, second floor hospital building, OT complex, Saveetha Medical College, Thandalam, Chennai 602105
Kancheepuram TAMIL NADU 602105 India |
Phone |
9566137571 |
Fax |
|
Email |
guna.kali@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Rohit Kamal |
Designation |
Post Graduate student |
Affiliation |
Saveetha Medical College and Hospital |
Address |
Anaesthesia department, second floor hospital building, OT complex, Saveetha Medical College, Thandalam, Chennai 602105
Kancheepuram TAMIL NADU 602105 India |
Phone |
9003133672 |
Fax |
|
Email |
rohankamal@gmail.com |
|
Source of Monetary or Material Support
|
Saveetha medical college hospital, Thandalam ,Chennai 602105 |
|
Primary Sponsor
|
Name |
Saveetha medical college hospital |
Address |
Saveetha medical college hospital, Thandalam, Chennai, Tamil Nadu 602105 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
rohit kamal |
Saveetha Medical College and Hospital |
obstetrics operation theatre , 1st floor, Saveetha medical college hospital, Thandalam, Chennai Chennai TAMIL NADU |
9003133672
rohankamal@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Saveetha Medical College |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Fixed dose bupivacaine |
Single shot Subarachnoid block with fixed dose of 2ml of 0.5 % hyperbaric bupivacaine + 10 microgram fentanyl. |
Intervention |
Height and weight based dosage of bupivacaine |
Single shot Subarachnoid block with 0.5 % hyperbaric bupivacaine based on height and weight (using Hartens chart) + 10 microgram fentanyl |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
1) 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
|
|
ExclusionCriteria |
Details |
1) 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
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
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
|
Outcome |
TimePoints |
Comparison of onset of sensory blockade in both the groups
|
every 30 seconds upto 10 minutes |
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 |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/07/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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. |