| CTRI Number |
CTRI/2021/02/031003 [Registered on: 04/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2021 |
| 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
|
To Compare TAP Block and surgical site infiltration with local anaesthesia for pain releif after caesarean section . |
|
Scientific Title of Study
|
Comparative Evaluation Of Bilateral Transversus Abdominis Plane Block With Multilayered Surgical Site Infiltration For Post Operative Analgesia Following Lower Segment Caeserean Section Using Pfanenstiel Incision Under Spinal Anaesthesia . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surbhi Taneja |
| Designation |
PG2 |
| Affiliation |
VMMC DELHI |
| Address |
Department of Anaesthesia and Intensive Care Vardhman Mahavir Medical College and Safdarjung Hospital ,Ansari nagar ,Delhi
South
East
DELHI
110023
India |
| Phone |
7814308390 |
| Fax |
|
| Email |
drsurbhitaneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suniti kale |
| Designation |
Consultant and professor and guide |
| Affiliation |
VMMC delhi |
| Address |
Department of anaesthesia and intensive care, VMMC and safdarjung hospital,ansari nagar ,New delhi
South
DELHI
110029
India |
| Phone |
9810287852 |
| Fax |
|
| Email |
findsuniti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suniti kale |
| Designation |
Consultant and professor and guide |
| Affiliation |
VMMC delhi |
| Address |
Department of anaesthesia and intensive care, VMMC and safdarjung hospital,ansari nagar ,New delhi
West
DELHI
110029
India |
| Phone |
9810287852 |
| Fax |
|
| Email |
findsuniti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir medical college and safdarjung hospital ,Ansari nagar New delhi pin code 110029 |
|
|
Primary Sponsor
|
| Name |
Surbhi taneja |
| Address |
Department of Anesthesia and intensive care VMMC and Safdarjung Hospital, Ansari nagar Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Surbhi Taneja |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care , Vardhman Mahavir Medical College and Safdarung Hospital ,Ansari Nagar ,New Delhi 110029
South
DELHI |
7814308390
drsurbhitaneja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O268||Other specified pregnancy relatedconditions, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multilayered surgical site wound infiltration for post op pain relief |
Multilayered surgical site wound infiltration done using 0.25 % bupivacaine for post op pain relief LSCS using pdannensteil incision |
| Intervention |
Transversus abdominis plane block |
Transversus abdominis plwane with 0.25% bupivacaine for post op pain relief post LSCS using pfannensteil incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
BMI more than 40kg /m2
Chronic pain
Psychiatric illness and inability to comprehend NRS scale
Long term use of opioids
Allergy to local anaesthetics
Previous LSCS or any other surgical scar on lower abdomen |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess post operative analgesia using Transversus abdominis plane Block with multilayered surgical site infiltration following Lower segment caesarean section using pfannenstiel incision under spinal Anaesthesia . |
0,30 min ,1hr ,2hr,4hr ,6hr ,12hr ,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare post operative hemodynamics
To compare the need for rescue analgesia betwen the two groups
To compare ambulation between the two groups |
0 ,30 min ,1hr ,2 hr ,4hr ,6hr,12hr ,24hr |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/02/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Contact author at drsurbhitaneja@gmail.com
- For how long will this data be available start date provided 01-01-2022 and end date provided 01-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study is prospective randomized interventional comparative study where two groups of patients will be compared for post operative pain relief .One group will receive TAP Block while other will be given multilayered surgical site wound infiltration after lower segment caesarean section under spinal anaesthesia. For TAP Block 20 ml of 0.25% of Bupivacaine on each side given .For multilayered surgical site wound infiltration total of 40 ml of 0.25% Bupivacaine which will be infiltrated in musculofascial and subdermal plane .
|