| CTRI Number |
CTRI/2021/09/036392 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
08/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare two drugs bupivacaine and ropivacaine in TAP block for pain relief after completion of surgery in patients undergoing caesarean section |
|
Scientific Title of Study
|
Comparision of bupivacaine 0.25% and ropivacaine 0.5% in transeversus abdominis plane block for postoperative analgesia in lower segment caesarean section |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hetal N Kanabar |
| Designation |
Assistant Professor in Anaesthesiology |
| Affiliation |
GMERS Medical College, Junagadh |
| Address |
Dr Hetal Kanabar, Assistant Professor, Department of Anaesthesia,Room no.310,GMERS Medical College and Hospital, Near Majevadi Gate, Junagadh. Gujarat.
Junagadh
GUJARAT
362001
India |
| Phone |
9909960401 |
| Fax |
|
| Email |
kanabarhetal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hetal N Kanabar |
| Designation |
Assistant Professor in Anaesthesiology |
| Affiliation |
GMERS Medical College, Junagadh |
| Address |
Dr Hetal Kanabar, Assistant Professor, Department of Anaesthesia, GMERS Medical College and Hospital, Near Majevadi Gate, Junagadh, Gujarat
Junagadh
GUJARAT
362001
India |
| Phone |
9909960401 |
| Fax |
|
| Email |
kanabarhetal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hetal N Kanabar |
| Designation |
Assistant Professor in Anaesthesiology |
| Affiliation |
GMERS Medical College, Junagadh |
| Address |
Dr Hetal Kanabar, Assistant Professor, Department of Anaesthesia, GMERS Medical College and Hospital, Near Majevadi Gate, Junagadh, Gujarat
Junagadh
GUJARAT
362001
India |
| Phone |
9909960401 |
| Fax |
|
| Email |
kanabarhetal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College, Paddock Road,Near Majevadi Gate, Junagadh, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Hetal N Kanabar |
| Address |
Dr Hetal Kanabar, 86, Prasadi, Street No.4, Raijinagar, NearMotibaug, Junagadh |
| 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 |
| Dr Hetal Kanabar |
GMERS medical college and hospital , junagadh |
407, obstetrics operation theatre,GMERS Medical College and Hospital,Paddock Road, Majevadi Gate, Junagadh
Junagadh
GUJARAT |
9909960401
kanabarhetal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMERS Medical College, Junagadh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj bupivacaine 0.25% via TAP block
|
Inj Bupivacaine 0.25% administered via Transeversus abdominis plane block 20 ml on each side (total 40 ml in a patient ) in Group B after completion of lower segment caesarean section. |
| Comparator Agent |
Inj Ropivacaine 0.5% via TAP block |
Inj Ropivacaine 0.5% administered via Transeversus abdominis plane block 20 ml on each side (total 40 ml in a patient) in Group R after completion of lower segment caesarean section |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA physical status 1 or 2, patients giving valid consent, undergoing elective lower segment caesarean section under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Known allergy to local anaesthetic agents, patients who are receiving any non-steroidal antiinflammatory drugs or opioids 48 hours prior to surgery, patients with any contraindication to spinal anaesthesia, thrombocytopenia, patients requiring general anaesthesia, local infection at the site of injection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First dose of rescue analgesic will be given when VAS Score more than or equal to 6 |
Upto 36 hours after giving TAP block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Local site infection or haematoma, any secondary complications of local anaesthetic agents such as cardiotoxicity or neurotoxicity |
Upto 36 hours after giving TAP block |
|
|
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)
|
15/09/2021 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized ,double blind ,parellel group, controlled trial comparing the safety and efficacy of bupivacaine 0.25% and ropivacaine 0.5% in transeversus abdominis plane block in 50 patients undergoing lower segment caesarean section ,will be conducted at GMERS Medical College, Junagadh. The primary outcome measures will be duration of analgesia that is from the time of giving TAP block to time of giving first rescue analgesic (when VAS Score more than or equal to 6 ). Secondary outcomes will be any local site infection or haematoma, any secondary complications of local anaesthetic agents such as cardiotoxicity or neurotoxicity. |