| CTRI Number |
CTRI/2021/05/033640 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
15/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two different types of block given over lower abdomen that carries nerves in patients who undergone caesarean section |
|
Scientific Title of Study
|
Comparing the effectiveness of USG guided transverse abdominis plane block and quadratus lumborum block for post operative pain management in lower segment caesarean section patients - A Randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika R |
| Designation |
First Year Post Graduate Resident |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,Melmaruvathur,Kancheepuram,Tamilndu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9655474730 |
| Fax |
|
| Email |
lovemakeslifebeautiful02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kumaresan Sathappan |
| Designation |
Associate Professor |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,Melmaruvathur,Kancheepuram,Tamilndu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9943641747 |
| Fax |
|
| Email |
drkums83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika R |
| Designation |
First Year Post Graduate Resident |
| Affiliation |
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesiology,Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,Melmaruvathur,Kancheepuram,Tamilndu 603319
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9655474730 |
| Fax |
|
| Email |
lovemakeslifebeautiful02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Melmaruavathur Aadhiparasakthi Institute of medical sciences and Research,Melmaruvathur,Kancheepuram,Tamil nadu, 603319 |
|
|
Primary Sponsor
|
| Name |
Melmaruvathur Aadhiparasakthi institute of Medical sciences and Research |
| Address |
Melmaruavthur,Kancheepuram,Tamil nadu,India 603319 |
| 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 |
| Dr R Deepika |
Melmaruvathur Aadhiparasakthi Institute of Medical sciences and Research |
Department of Anaesthesiology,Obstetrics and gynaecology operation theatre,post operative recovery room,Operation theatre complex,B Zone,First floor,Hospital block,Kanchepuram,Tamil nadu
Kancheepuram
TAMIL NADU |
9655474730
lovemakeslifebeautiful02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee,Melmaruvathur Aadhiparasakthi Institute of Medical sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus lumborum nerve block |
A 21G needle is inserted into thoracolumbar fascia middle layer under ultrasound guidance,then 0.2ml/kg of 0.2% Ropivacaine is injected as a single shot for Quadratus lumborum nerve block and the same procedure is repeated on other side also |
| Comparator Agent |
Transverse Abdominis plane nerve block |
A 21G needle is inserted between the internal oblique and transverse Abdominis muscle at the most posterior end of Transversus Abdominis Plane under ultrasound guidance,then 0.2ml/kg of 0.2% Ropivacaine is injected as a single shot for Transverse Abdominis Plane nerve block and the same procedure is repeated on other side also |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA 2 patients undergoing caesarean section |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA 3 and 4
Coagulapathies/coagulation disorders
Anatomic abnormalities of spinal cord
Allergy to study medications
Localized infections |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of usg guided transverse abdominal plane block vs quadratus lumborum block in patients undergoing lower segment caesarean section using a VAS score at rest and with movement |
0hr,1hr,2hr,4hr,6hr,12hr,24hr,36hr,48hr,72hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate time for rescue analgesic requirement between transverse abdominus plane block and quadratus lumborum block |
the time at which the first dose of analgesia needed |
| to calculate the total number of analgesic doses required |
for a period of 72 hours |
| hemodynamic parameters |
0hr,1hr,2hr,4hr,6hr,12hr,24hr,36hr,48hr,72hr |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
01/06/2021 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - lovemakeslifebeautiful02@gmail.com
- For how long will this data be available start date provided 01-06-2021 and end date provided 01-06-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized controlled trial comparing the effectiveness of USG guided transverse abdominis plane block and quadratus lumborum block for post operative pain management in lower segment caesarean that will be conducted in Melmaruvathur Aadhiparasakthi institute of medical sciences and research.Primary outcome will be comparing the effectiveness of these two blocks using VAS score at rest and with movement.Secondary outcome will be to evaluate the time required for rescue analgesia between these two blocks and to calcuate the total number of doses required over a period of 72 hours. |