CTRI Number |
CTRI/2021/05/033512 [Registered on: 10/05/2021] Trial Registered Prospectively |
Last Modified On: |
08/05/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A comparative study of two methods of nerve block (during surgery and the other after surgery) for pain on pain relief after cesarean section |
Scientific Title of Study
|
Analgesic effectiveness of surgically administered transversus abdominis plane block versus conventional transversus abdominis plane block in elective caesarean sections – an open labelled randomised control trial. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Jahnavi Jayakumar J |
Designation |
Postgraduate |
Affiliation |
Bangalore Baptist Hospital |
Address |
Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka Bangalore KARNATAKA 560024 India |
Phone |
08861138840 |
Fax |
|
Email |
jahnavijay@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shiny Varghese |
Designation |
Head of the Department |
Affiliation |
Bangalore Baptist Hospital |
Address |
Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka Bangalore KARNATAKA 560024 India |
Phone |
9880632522 |
Fax |
|
Email |
shinyashishvarghese@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shiny Varghese |
Designation |
Head of the department |
Affiliation |
Bangalore Baptist Hospital |
Address |
Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka Room number 137, department of OBG, Bangalore Baptist Hospital, Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka Bangalore KARNATAKA 560024 India |
Phone |
9880632522 |
Fax |
|
Email |
shinyashishvargheses@gmail.com |
|
Source of Monetary or Material Support
|
Bangalore Baptist Hospital |
|
Primary Sponsor
|
Name |
Bangalore Baptist Hospital |
Address |
Bellary Rd, Vinayakanagar, Hebbal, Bengaluru, Karnataka |
Type of Sponsor |
Research institution and hospital |
|
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 Jahnavi Jayakumar |
Bangalore Baptist hospital |
OPD no 137, Department of OBG, Bangalore Baptist Hospital
bellary road Hebbal Bangalore KARNATAKA |
8861138840
jahnavijay@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Review board, Bangalore Baptist Hospital |
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 |
Comparator Agent |
Conventional TAP block with 0.25% Bupivacaine 25 ml each side |
Patients in Group B will receive conventional TAP block with 0.25% Bupivacaine 25 ml each side. The conventional TAP will be performed by the anesthesiologist, under ultrasound-guidance, after the completion of surgery. |
Intervention |
Surgically administered TAP block with 0.25% Bupivacaine 25 ml each side |
In participants allocated to Group A after the completion of uterine closure and confirmation of haemostasis, surgical TAP block will be administered by operating surgeon using a technique adapted from the description by Owen et.al. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
1. Pregnant women undergoing elective caesarean section under spinal anaesthesia
2. Age group of 18-40 years.
3. ASA grade I or II.
|
|
ExclusionCriteria |
Details |
1. Patient refusal
2. If vertical abdominal incision was required
3. Planned duration of surgery more than two hours
4. Having blood loss greater than 2 L
5. Thrombocytopenia
6. Coagulopathy or anti-coagulation treatment (INR>1.5)
7. History of allergy to the study drug
8. Body Mass Index (BMI) <18 or >35 Kg/m2
9. Patients with hypertensive disorders
10. Alcohol or drug abuse.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Time to rescue analgesia |
Before 24 hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
• Time taken to perform the TAP block |
AT THE TIME OF PROCEDURE |
Amount of rescue analgesia |
Before 24 hours |
|
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)
|
14/05/2021 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
not done |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Caesarean section delivery is becoming more
frequent and at present is one of the most common major operative procedures
performed worldwide. It is important that effective
postoperative analgesia is provided to facilitate early ambulation, infant care
(which also includes breast feeding, mother infant bonding) and prevention of
postoperative morbidity. Therefore, the analgesic regimen needs to meet the
goals of providing safe and effective analgesia with minimal side effects for
the mother and the neonate. TAP block as a part of multimodal analgesic regimen
would result in decreased opioid and NSAID consumption and improved analgesia.
TAP block is conventionally performed by the anaesthesiologist, using a
percutaneous approach under ultrasound-guidance. The surgically administered
TAP block is a variant of TAP block administration, the efficacy of which in
comparison to the conventional TAP block as a part of multimodal analgesic
regimen following caesarean section is not very widely studied till date. Our
study is designed to assess if the newly described surgical TAP block is as
effective as the conventional TAP block (by comparing the requirement of rescue
analgesia in both the groups) for post-operative analgesia following caesarean
section in the Indian set-up in which surgical TAP block prove to be an easier
procedure as there no the need for skilled operators or specialized equipment. |