| 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
|
|
|
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
|
|
|
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 |