| CTRI Number |
CTRI/2023/02/049768 [Registered on: 15/02/2023] Trial Registered Prospectively |
| Last Modified On: |
09/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
A clinical study to determine the effect of anaesthetics in lower segment caesarean section. |
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Scientific Title of Study
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To determine the effectiveness of 0.125% Bupivacaine (20 ml) vs 0.1875% Ropivacaine (20ml) in ultrasound guided transversus abdominis plane block for providing postoperative analgesia after elective lower segment caesarean section with Pfannenstiel incision under subarachnoid blockade: A Prospective, Randomised, Double blind, Clinical study.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shriker Sangviker |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9916841259 |
| Fax |
|
| Email |
dr.shriker@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Shwetha Odeyar S |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9481150325 |
| Fax |
|
| Email |
odeyarshwetha@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Shriker Sangviker |
| Designation |
Junior Resident |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9916841259 |
| Fax |
|
| Email |
dr.shriker@gmail.com |
|
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Source of Monetary or Material Support
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| BGS Global Institute of Medical Sciences, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India |
|
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Primary Sponsor
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| Name |
BGS Global Institute of Medical Sciences |
| Address |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri, Bangalore 560060, Karnataka, India |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shriker Sangviker |
BGS Global Institute of Medical Sciences |
Pre-operative room and OT 9 and 10, Labour OT Complex, Obstetric wards, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9916841259
dr.shriker@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
20 ml of 0.125% Bupivacaine |
Ultrasound guided TAP block performed with 20 ml each side of 0.125% Bupivacaine after completion of surgery |
| Comparator Agent |
20 ml of 0.1875% Ropivacaine |
Ultrasound guided TAP block performed with 20 ml each side of 0.1875% Ropivacaine after completion of surgery |
|
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA Physical status II parturients.
2.Parturients undergoing elective lower segment caesarean section using Pfannenstiel incision under subarachnoid blockade.
3.Height of parturient: 150 cms to 170 cms.
4.Weight of parturient 50 kgs to 90 kgs.
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| ExclusionCriteria |
| Details |
1.Patient refusal or unable to give written informed consent. E.g.: psychiatric patients
2.Patients with known allergy to study drugs
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) score |
Baseline, After subarachnoid blockade, Before TAP block, 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours |
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Secondary Outcome
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| Outcome |
TimePoints |
| Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean arterial pressure, Room air saturation of oxygen (SpO2), Time to first mobilisation, Time of rescue analgesic use, Side effects |
Baseline, After subarachnoid blockade, Before TAP block, 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours |
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Target Sample Size
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Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
22/02/2023 |
| 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 |
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Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
A
prospective, randomised, double blind, clinical study to compare effectiveness
of bilateral ultrasound guided TAP block with 20 ml each side of 0.125%
bupivacaine vs 0.1875% ropivacaine after
subarachnoid block in all parturients aged between 19 and 40 years, height
between 150 and 170cms weighing between 50 and 90 kgs belonging to ASA Physical
status II undergoing elective lower segment caesarean section with Pfannenstiel
incision for a duration of 6 months at BGS Global Institute of Medical
Sciences, Bangalore. |