| CTRI Number |
CTRI/2019/03/017917 [Registered on: 05/03/2019] Trial Registered Retrospectively |
| Last Modified On: |
28/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Postoperative pain relief after caesarean section |
|
Scientific Title of Study
|
Efficacy of 0.2% Ropivacaine in surgeon assisted transverse abdominis plane block for postoperative analgesia after caesarean delivery (Performed under spinal anaesthesia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khemraj Meena |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Rajasthan University of Health Sciences, Jaipur |
| Address |
Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
khemraj10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Khemraj Meena |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
Rajasthan University of Health Sciences, Jaipur |
| Address |
Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9414759782 |
| Fax |
|
| Email |
khemraj10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chandraprakash Kalwar |
| Designation |
Junior Resident, Department of Anaesthesiology |
| Affiliation |
Rajasthan University of Health Sciences, Jaipur |
| Address |
Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9166280775 |
| Fax |
|
| Email |
doc84kal@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNT Medical College, Udaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Chandra Prakash Kalwar |
| Address |
Deaprtment of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan |
| 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 |
| Khemraj Meena |
RNT Medical College, Udaipur |
Department of Anaesthesiology, RNT Medical College, Udaipur, Rajasthan
Udaipur
RAJASTHAN |
9414759782
khemraj10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, RNT Medical College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Asa grade II, (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Transverse abdominis plane block |
0.20% Ropivacaine 20 ml each side.Duration of post-operative analgesia the time of need for the first dose of rescue analgesia (VAS ≥ 3) will be noted.Inj. Tramadol i.v. 2 mg/kg will be used as rescue analgesia and dosages required during 48 hourly in postoperative period |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patient giving willful consent |
|
| ExclusionCriteria |
| Details |
Patient Refusal, ASA grade >II, Age<18 years, BMI >35 kg/m2, Complicated pregnancy, Patient with known hypersensitivity to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Analgesia |
at VAS 3 or more |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of first rescue analgesia
Total dose consumption of rescue analgesia
Post discharge satisfaction
Adverse events |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2017 |
| Date of Study Completion (India) |
31/10/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the efficacy of 0.2% Ropivacaine in surgeon assisted tratransve abdominis plane block for popostoperative analgesia after caesarean delivery performed under spinal anaesthesia |