| CTRI Number |
CTRI/2021/07/034633 [Registered on: 06/07/2021] Trial Registered Prospectively |
| Last Modified On: |
02/07/2021 |
| 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
|
Effect of transversus abdominis plane block in lower segment caesarean section with comparative study of efficacy and safety of bupivacaine and ropivacaine. |
|
Scientific Title of Study
|
A comparative study of efficacy and safety of transversus abdominis plane block with bupivacaine and ropivacaine for post-operative analgesia following lower segment caesarean section:A prospective, randomized, controlled, double blind study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Susheela Choudhary |
| Designation |
Postgraduate resident |
| Affiliation |
JLN Medical college Ajmer |
| Address |
Department of anesthesiology New OT JLN medical college Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
8058376584 |
| Fax |
|
| Email |
susheelachoudhary2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor & Head of Department |
| Affiliation |
JLN Medical college Ajmer |
| Address |
Department of anesthesiology New OT JLN medical college Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
941408276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Patodi |
| Designation |
Senior Professor & Head of Department |
| Affiliation |
JLN Medical college Ajmer |
| Address |
Department of anesthesiology New OT JLN medical college Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN MEDICAL COLLEGE AJMER |
|
|
Primary Sponsor
|
| Name |
JLN Medical college Ajmer |
| Address |
Department of anaesthesiology, JLN medical college Ajmer, Rajasthan |
| Type of Sponsor |
Government 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 Susheela Choudhary |
JLN medical college Ajmer |
New OT Department of anesthasiology JLN medical college Ajmer Rajasthan
Ajmer
RAJASTHAN |
8058376584
susheelachoudhary2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JLN Medical college Ajmer |
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 |
| Intervention |
inj Bupivacaine 0.25% in transversus abdominis plane block in spinal anesthesia. |
Transversus abdominis plane block using Bupivacaine 0.25% 15ml+15ml bilaterally at petit triangle is given once above iliac creast using anatomical landmark guided tecnique,Block is given after surgery only ONCE to the patient of study. |
| Comparator Agent |
Inj Ropivacaine 0.25% in transversus abdominis plane block in spinal anesthesia. |
Transversus abdominis plane block using Ropivacaine 0.25% 15ml+15ml bilaterally at petit triangle is given once above iliac creast using anatomical landmark guided tecnique,Block is given after surgery only ONCE to the patient of study. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant patients between 20years -35 years
Informed consent for participation in study
ASA physical 1& 2
Elective or non-urgent lower segment caesarean section |
|
| ExclusionCriteria |
| Details |
Age less than 20 years and above 35 years
Patients not willing to participate in the study
Any hypersensitivity or contraindication to local anaesthetics
Patient with chronic pain or on long-term analgesics
contraindication to spinal anaesthesia like local infection at the site of lumbar puncture,any bleeding disorders like thrombocytopenia,space occupying lesion of the brain,anatomical disorders of the spine,hypovolemia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of number and frequency of post operative analgesia required in both the groups for first 24h postoperatively to assess the effective analgesia by visual analog scale (VAS) score |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the hemodynamic changes.
To assess and compare the proportion of patients having adverse effect and other complication. |
Around 1 year |
|
|
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)
|
13/07/2021 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Aim of our study to assess the efficacy of transversus abdominis plane block (TAP) for post operative analgesia in patient under going lower segment ceasarean section under spinal anasthesia by creating a comparison between ropivacaine (0.25%) and bupivacain(0.25%). |