| CTRI Number |
CTRI/2017/08/009249 [Registered on: 03/08/2017] Trial Registered Prospectively |
| Last Modified On: |
02/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [pain relief] |
| Study Design |
Other |
|
Public Title of Study
|
a clinical trial to compare efficacy of the analgesic activity of inj. Bupivacaine vs inj. Ropivacaine given at transverse abdominis block and also compare the safety parameters also. |
|
Scientific Title of Study
|
“Clinical evaluation of efficacy and safety of transversus abdominis plane block inj. Bupivacaine vs. inj. Ropivacaine for post operative analgesia following lower segment cesarean 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 Ravikumar Parmar |
| Designation |
M.D. Anaesthesiology, Assistant Professor |
| Affiliation |
Government Medical College, Bhavnagar. |
| Address |
Dept. of Anaesthesiology, Govt. Medical College, Bhavnagar - 364001, Gujarat, India.
Govt. Medical College, Jail road,Bhavnagar - 364001, Gujarat, India.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9099097807 |
| Fax |
02782422011 |
| Email |
ravirajparmar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravikumar Parmar |
| Designation |
M.D. Anaesthesiology, Assistant Professor |
| Affiliation |
Government Medical College, Bhavnagar. |
| Address |
Dept. of Anaesthesiology, Govt. Medical College, Bhavnagar - 364001, Gujarat, India.
Govt. Medical College, Jail road,Bhavnagar - 364001, Gujarat, India.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9099097807 |
| Fax |
02782422011 |
| Email |
ravirajparmar1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravikumar Parmar |
| Designation |
M.D. Anaesthesiology, Assistant Professor |
| Affiliation |
Government Medical College, Bhavnagar. |
| Address |
Dept. of Anaesthesiology, Govt. Medical College, Bhavnagar - 364001, Gujarat, India.
Govt. Medical College, Jail road,Bhavnagar - 364001, Gujarat, India.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9099097807 |
| Fax |
02782422011 |
| Email |
ravirajparmar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sir Takhtsinhji general Hospital, jail road,Bhavnagar – 364001, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
4th floor, Sir Takhtsinhji general Hospital, jail road,Bhavnagar – 364001, Gujarat, India. |
| 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 Ravikumar Parmar |
Sit Takhtsinhji General Hospital |
Kalanala, jail road, Bhavnagar – 364001, Gujarat, India.
Bhavnagar
GUJARAT |
9099097807
02782422011
ravirajparmar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Government Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
lower segment cesarean section indication |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
inj. Bupivacaine |
trnsverse abdominis plane block of bupivacaine 0.25% 15 ml bilaterally, |
| Comparator Agent |
inj. Ropivacaine |
transversus abdominis plane block inj. ropivacaine 0.25% 15 ml bilaterally |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
 Informed written consent for
participation in study.
 Age: 20-35 years
 Gender: Antenatal female patients
scheduled for elective or non urgent
lower segment cesarean section.
 ASA physical status I and II.
 Patients refusing consent.
|
|
| ExclusionCriteria |
| Details |
1.Contraindications to Spinal Anaesthesia like,
Local infection or sepsis at the site of
Lumbar puncture
Bleeding disorders, thrombocytopenia
Space occupying lesions of the brain
Anatomical disorders of the spine
Hypovolaemia e.g. following massive
haemorrhage
2.Allergy to local anaesthetic drugs and NSAIDS.
3.Patient on any form of analgesics therapy.
4.BMI ≥ 25 kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy and safety of bupivacaine and ropivacaine for post operative pain relief in lower segment cesarean section with Visual Analogue Score and total dose of rescue analgesia. |
1st day of lower cesarean section(First 24 hours after lower segment cesarean section) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect on hemodynamic variables like Heart Rate (HR), Mean Arterial Pressure (MAP), Oxygen saturation (SpO2).
Side effects & Complications if any.
|
1st day of lower segment cesarean section (24 hours of lower segment cesarean section) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
20/09/2017 |
| 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
|
will be published in well reputted journal with pubmed index and some impact factor |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
study is prospective, randomized, controlled, double blind study parallel
group, comparing the safety and efficacy of bupivacaine and ropivacaine in transversus
abdominis plane block after lower segment cesarean section.
In
this study bupivaiane will be given in transversus abdominis plane block after
lower segment cesarean section in dose of 0.25% 15 ml bilataerally an in other
group ropivacainewill be given in dose of 0.25% 15 ml bilataerally
The
primary outcome is- To compare efficacy and safety of bupivacaine and ropivacaine for post operative pain relief in lower
segment cesarean section with Visual Analogue Score and total dose of rescue
analgesia.
The secondary outcomes are- Effect on hemodynamic variables like Heart Rate
(HR), Mean Arterial Pressure (MAP), Oxygen saturation (SpO2).
Side
effects & Complications if any. |