| CTRI Number |
CTRI/2024/04/065280 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/04/2024 |
| 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
|
Studying two different ways to use ultrasound to ease pain after lower abdominal surgery. One method involves the drug administration on the side of the patient, while the other method involves the drug administration on the backside of the patient. |
|
Scientific Title of Study
|
Comparison of lateral versus posterior technique of ultrasound guided transverse abdominis plane block for postoperative analgesia in lower abdominal surgeries under spinal anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abirami S |
| Designation |
Post graduate |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of anaesthesiology, Saveetha medical college and hospital,Chennai
Tamil nadu - 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
8110953985 |
| Fax |
|
| Email |
abishanmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rathna |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of anaesthesiology, Saveetha medical college and hospital,Chennai
Tamil nadu - 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9940475385 |
| Fax |
|
| Email |
drrathna86@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathna |
| Designation |
Professor |
| Affiliation |
Saveetha medical college and hospital |
| Address |
Department of anaesthesiology, Saveetha medical college and hospital,Chennai
Tamil nadu - 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9940475385 |
| Fax |
|
| Email |
drrathna86@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital, Thandalam, Chennai,Tamil nadu, India
Pin code - 602105 |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha nagar Thandalam
Chennai Bengaluru NH 48
Chennai
Tamilnadu 602105 |
| 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 |
| DrAbirami S |
Saveetha medical college and hospital |
Operation theatre complex, Department of anaesthesia, Saveetha nagar
Chennai
TAMIL NADU |
8110953915
abishanmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital institutional ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
All patients undergoing lower abdominal surgeries under spinal anesthesia |
TAP block in posterior approach |
| Intervention |
All patients undergoing lower abdominal surgeries under spinal anesthesia |
TAP block in lateral approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and2
Patients undergoing lower abdominal surgeries under spinal anesthesia
Patients willingness to participate |
|
| ExclusionCriteria |
| Details |
Age less than 18 more than 60
Patient refusal
Infection at the site of block
Coagulation bleeding disorder
Patient with cardiovascular,pulmonary,neurological disorder |
|
|
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 |
| Assess postoperative analgesia duration |
Time to vas 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare better duration of analgesi effect with lateralor posterior approach Tap block |
Duration in hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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 Applicable |
| 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 this study we would like to compare the analgesic efficacy of lateral and posterior appproach of ultrasound guided transverse abdominis plane block for postoperative analgesia in patients under going lower abdomen surgeries under spinal anesthesia Intraoperative BP and PR measured at 0,5,10 and 30 mins Postoperatively PR and BP at every 20 mins for first 2 hours and at 4,6,12 and 24 hours Post operative VAS score in 2,4,6,12,and 24 hours Duration of onset of pain and motor power in hours Thank you |