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CTRI Number  CTRI/2024/02/063070 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Other (Specify) [obstetrics post caesarean analgesia]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of TAP block to manage pain after caesarean section 
Scientific Title of Study   Effect of transverse abdominal plane block use in post-caesarean analgesia: A randomised double blind study 
Trial Acronym  TAP block RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manasvi Chennakeshava  
Designation  Assistant professor, department of OBG 
Affiliation  Siddaganga Medical College and research institute  
Address  Department of obstetrics and gynaecology Siddaganga medical college and research centre Shree Shivakumaraswamiji road Tumakuru 572102 Karnataka

Tumkur
KARNATAKA
572102
India 
Phone  8197107149  
Fax    
Email  mnsv18121989@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manasvi Chennakeshava  
Designation  Assistant professor, department of OBG 
Affiliation  Siddaganga Medical College and research institute  
Address  Department of obstetrics and gynaecology Siddaganga medical college and research centre Shree Shivakumaraswamiji road Tumakuru 572102 Karnataka


KARNATAKA
572102
India 
Phone  8197107149  
Fax    
Email  mnsv18121989@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajani  
Designation  Assistant professor  
Affiliation  Siddaganga Medical College and research institute  
Address  Department of obstetrics and gynaecology Siddaganga medical college and research centre Shree Shivakumaraswamiji road Tumakuru 572102 Karnataka

Tumkur
KARNATAKA
572102
India 
Phone  8606605516  
Fax    
Email  kuttu2412@gmail.com  
 
Source of Monetary or Material Support  
Siddaganga medical college and research institute Dr. shree shivakumara swamiji road Tumakuru 572101 
 
Primary Sponsor  
Name  Siddaganga medical college and research institute  
Address  Siddaganga Medical College and research institute shree shivakumaraswamiji road tumakuru  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manasvi  Siddaganga medical college and research centre  Obstetrics ward, room no 204, 2nd floor. Shree shivakumaraswamiji road Tumkuru Karnataka
Tumkur
KARNATAKA 
8197107149

mnsv18121989@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of siddaganga medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided TAP block using Bupivacaine  Bupivacaine 0.25% 20ml on each side after closing abdomen , single dose. Post op analgesia is studied for 24 hours 
Comparator Agent  Ultrasound guided TAP block using normal saline as placebo  Normal saline 0.9% 20ml on each side after closing abdomen, single dose. Post operative analgesia is studied for 24 hours 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All women admitted for caesarean section under spinal anaesthesia
With age 21-40
Body mass index 19-30kg/m2
Haemoglobin level more than 9gm/dl 
 
ExclusionCriteria 
Details  Women who fail to give consent
Women with comorbidities -epilepsy, heart disease, psychological disease
Women with intra-op complications- postpartum haemorrhage
Women with postoperative complications
Women with known allergy to any drugs
Women on analgesics 
 
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 assess whether TAP block results in a clinically significant reduction in postoperative pain after caesarean delivery during first 24 hours  To assess whether TAP block results in a clinically significant reduction in postoperative pain after caesarean delivery at 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 18 hours, 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. First rescue dose of analgesia   Less than 4 hours or after 4 hours 
Number of extra doses of analgesia required   Till 24 hours post delivert 
Time of first ambulation  Less than 6 hours or more than 6 hours 
Side effects of TAP reported   Till 24 hours  
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   01/03/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

In cesarean delivery, TAP block represents a convenient primary analgesic for women not receiving neuraxial morphine for any reason. TAP block is an assisting analgesic technique used to decrease either the use of opioids during the intraoperative period or the use of systemic analgesics for postoperative pain management. The TAP block is a field block of the thoracolumbar nerves, running in the fascial plane between the internal oblique muscle and the transversus abdominis muscles. The anterior primary rami course between the internal oblique and the transversus abdominis muscles and subsequently branch into the lateral and anterior cutaneous nerves at approximately the midaxillary line.

Study procedure:

 

This will be a double blinded study where the study participant and the investigator is blinded. Anaesthetist who will perform the block will not be blinded.

After obtaining clearance from institutional ethical committee, Study participants admitted for Caesarean section under spinal anaesthesia will be randomly allocated at admission to either the TAP block group or the control group by sealed opaque envelope method by the staff nurse of the ward. Consent will be obtained after informing about the study from both groups.

The TAP block group will receive landmark-orientated, bilateral TAP block in the triangle of Petit by loss of resistance method after closure of the abdomen by anaesthetist. Drug used will be bupivacaine 0.25% 20 ml on each side. Control group will receive placebo- 20 ml 0.9% normal saline bilaterally at the same landmark. 

 

Intra operative monitoring of blood pressure , pulse rate, saturation, will be done for both groups. 

 

After completion of the procedure, study participants will be  shifted to the post anaesthesia care unit  before transferring them to the ward. 

Demand for first rescue analgesia will be studied in both groups. Both the groups will receive a standard post-operative analgesic regimen with 1gm/100ml paracetamol every 12 h and 50 mg IV tramadol on demand for breakthrough pain. 

All the subjects will be assessed at  2, 4, 8, 12, 18 & 24 h after surgery for pain at rest & on movement. 

All the subjects will be asked to rate their pain at rest and on movement using a visual analogue scale (VAS) with ‘0’ representing no pain and ‘10’ being the worst imaginable pain. Supplemental analgesia (50 mg tramadol IV) will be administered if VAS > 4 on movement or if the mother demanded for it. 

If no supplemental analgesia was given within 12 h of surgery, regular dose of paracetamol will be administered to both groups.

Time at first ambulation will be studied in both groups.

Total doses of tramadol and paracetamol given at the end of 24 hours in both groups will be assessed. 

At the end of the study, mothers will be asked to rate their satisfaction with the pain management in a 3-point scale (1- dissatisfied, 2- satisfied, 3- highly satisfied)

 

Recorded data will be analysed with the help of statistician.

 

After ethical committee clearance from the institution, this trial will be registered witrh central trial registry of India

 
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