| CTRI Number |
CTRI/2024/05/067445 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the difficulties in visualising the abdominal muscle layers during abdominal plane block using Ultrasound in laparoscopic surgeries |
|
Scientific Title of Study
|
Technical Difficulties in Ultrasound guided transversus abdominis plane block:A comparative study |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devesh Yadav |
| Designation |
junior resident |
| Affiliation |
7 Air force hospital Kanpur |
| Address |
Department of Anaesthesia , 7 AFH KANPUR , Nathu singh road, kanpur cantt, kanpur
Department of Anaesthesia , 7 AFH KANPUR , Nathu singh road, kanpur cantt, kanpur
Kanpur Nagar
UTTAR PRADESH
208004
India |
| Phone |
8287680270 |
| Fax |
|
| Email |
pan2dev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Kumar Patra |
| Designation |
asst prof |
| Affiliation |
7 Air force hospital Kanpur |
| Address |
Department of Anaesthesia , 7 AFH KANPUR , Nathu singh road, kanpur cantt, kanpur
Department of Anaesthesia , 7 AFH KANPUR , Nathu singh road, kanpur cantt, kanpur
Kanpur Nagar
UTTAR PRADESH
208004
India |
| Phone |
7985158219 |
| Fax |
|
| Email |
arun_drarun@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Arun Kumar Patra |
| Designation |
asst prof |
| Affiliation |
7 Air force hospital Kanpur |
| Address |
Department of Anaesthesia , 7 AFH KANPUR , Nathu singh road, kanpur cantt, kanpur
Department of Anaesthesia , 7 AFH KANPUR , Nathu singh road, kanpur cantt, kanpur
Kanpur Nagar
UTTAR PRADESH
208004
India |
| Phone |
7985158219 |
| Fax |
|
| Email |
arun_drarun@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| 7 Air force hospital Kanpur |
|
|
Primary Sponsor
|
| Name |
Air Force Hospital |
| Address |
Department of Anaesthesia
7 AFH KANPUR
Nathu singh road
kanpur cantt
UP 208004 |
| 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 |
| DrDevesh Yadav |
7 Air force hospital |
Department of Anaesthesia , 7 AFH KANPUR , Nathu singh road, kanpur cantt, kanpur
Kanpur Nagar
UTTAR PRADESH |
8287680270
pan2dev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 7 Air force hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Postoperative TAP block |
Gr B ( Comparator arm) patients will receive 0.5% Bupivacaine +4mg Dexamethasone in Transverse abdominis plane injections under ultrasound guidance, after the surgery before extubation. |
| Intervention |
Preoperative TAP block |
Gr A ( Intervention arm) patients will receive the 0.5% Bupivacaine +4mg Dexamethasone in Transverse abdominis plane injections under Ultrasound guidance, prior to surgery after induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age grp 18 yrs to 60 yrs groups and both gender.
Under ASA-1,2 undergoing laparoscopic surgeries. |
|
| ExclusionCriteria |
| Details |
Patients allergic to local anaesthetic drugs |
|
|
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 |
| Visualization of abdominal plans in pre TAP block group and post TAP block group |
In pre TAP block,10 mins after intubation.
In post TAP block,10 mins before Extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post op pain score
Rescue analgesia |
At 0 hr,6 hrs,24 hrs.
In 0 hr after surgery and 6 hr after surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
31/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Ultrasound guided TAP block is a routine practice in most of the institutions as a method of pain management in laparoscopic surgeries. however, the there is recommendations or guidelines regarding the timing of such intervention. We proposed the technical challenges are more with TAP block when administered after the surgeries compared to intervention before the beginning of the surgery.
The purpose of the study will be to visualise the abdominal planes using ultrasound in patients undergoing laparoscopic surgeries and also to find out the ease of infiltrating the drug at the desired site
The study will commence on 01 jun 2024 after recruitting patients as per inclusion and exclusion criteria. The data will be collected in an excel sheet and will be analysed appropritely.
|