| CTRI Number |
CTRI/2024/07/071137 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| 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
|
LSCS patients will be given Block with bupivacaine and bupivacaine with Dexamethasone and assessment of postoperative pain done |
|
Scientific Title of Study
|
Comparison of Bupivacaine vs Bupivacaine with Dexamethasone in Transverse Abdominis Plane block for postoperative analgesia in lower segment cesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Singh |
| Designation |
Postgraduate |
| Affiliation |
Peoples College of Medical Sciences |
| Address |
Room no 1 first floor Department of anaesthesia peoples hospital peoples College of Medical sciences karond bypass road bhanpur bhopal madhyapradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7985522933 |
| Fax |
|
| Email |
drabhisheksingh.iimsr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhilekh Jain |
| Designation |
Professor |
| Affiliation |
Peoples College of Medical Sciences |
| Address |
Room no 2 first floor Department of anaesthesia peoples hospital peoples college of Medical Sciences karond bypass road bhanpur bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9827606268 |
| Fax |
|
| Email |
jainabhilekh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Singh |
| Designation |
Postgraduate |
| Affiliation |
Peoples College of Medical Sciences |
| Address |
Room no 1 first floor Department of anaesthesia peoples hospital peoples College of Medical sciences karond bypass road bhanpur bhopal madhyapradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
7985522933 |
| Fax |
|
| Email |
drabhisheksingh.iimsr@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples hospital peoples College of Medical Sciences karond bypass road bhanpur bhopal Madhya Pradesh India 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples College of Medical Sciences And Research Centre |
| Address |
Peoples Hospital Peoples College of Medical Sciences karond bypass road bhanpur bhopal Madhya Pradesh 462037 |
| 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 Abhishek Singh |
Peoples hospital |
Room no 1 first floor Department of anaesthesia Peoples hospital peoples College of Medical Sciences and Research Centre karond bypass road bhanpur bhopal 462037
Bhopal
MADHYA PRADESH |
7985522933
drabhisheksingh.iimsr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Peoples College of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine |
Patients undergoing lower segment cesarean section will be administered with TAP block with 20 ml Bupivacaine alone and will be assessed for 300 minutes |
| Intervention |
Bupivacaine with Dexamethasone |
Patient undergoing lower segment cesarean section will be given TAP block with 20ml bupivacaine and 0.1mg/kg dose Dexamethasone and will be assessed for 300 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 and 2
Patients for elective LSCS |
|
| ExclusionCriteria |
| Details |
ASA grade 3 and above
Patient refusal
Patients with comorbid conditions like asthma cardiac disease epilepsy
Patient on antipsychotic and antiarrhythmic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesia |
At baseline after every 10minutes upto 300 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic parameters |
At baseline & every 10 minutes upto 300 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a postgraduate thesis. Patients undergoing elective lower segment cesarean section will be divided into 2 groups and given transverse abdominis plane block with 20ml bupivacaine versus 20ml bupivacaine with 0.1mg/kg Dexamethasone. These patients will be assessed and compared for postoperative analgesic effect and haemodynamic parameters in the 2 groups with the help of visual analog score. |