| CTRI Number |
CTRI/2026/03/105183 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing analgesic effectiveness between posterior versus lateral transversus abdominis plane block techniques for patients undergoing lower abdominal surgeries |
|
Scientific Title of Study
|
A comparative study of analgesic effectiveness between posterior versus lateral transversus abdominis plane block techniques in patients undergoing lower abdominal surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nazia banu J |
| Designation |
Assistant professor |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Assistant professor department of anaesthesiology Bangalore medical College and research institute k r road kalasipalya bangalore
K R ROAD KALASIPALYA BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
8618814997 |
| Fax |
|
| Email |
naaz.banu2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nazia banu J |
| Designation |
Assistant professor |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Assistant professor department of anaesthesiology Bangalore medical College and research institute k r road kalasipalya bangalore
K R ROAD KALASIPALYA BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
8618814997 |
| Fax |
|
| Email |
naaz.banu2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj gowda P |
| Designation |
Post graduate |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
Department of anaesthesiology Bangalore medical College and research institute k r road kalasipalya bangalore
K R ROAD KALASIPALYA BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
8310243717 |
| Fax |
|
| Email |
gowdamanoj9932@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical College and research institute k r road kalasipalya bangalore karnataka India 560002 |
|
|
Primary Sponsor
|
| Name |
Dr Nazia banu J |
| Address |
Department of anaesthesiology Bangalore medical College and research institute k r road kalasipalya bangalore karnataka India 560002 |
| 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 |
| Dr Nazia banu J |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Department of anaesthesiology k r road kalasipalya bangalore 560002
Bangalore
KARNATAKA |
8618814997
naaz.banu2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee of bangalore medical college and research institute |
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 |
Lateral transversus abdominis plane block |
After lower abdominal surgical procedure under spinal anaesthesia ultrasound guided lateral transversus abdominis plane block single administration using 20 ml of 0.25% bupivacaine on bilateral side procedure duration approximately 5-10 minutes on each side injected in the fascial plane between internal oblique and transversus abdominis muscle at the mid-axillary line in patients undergoing elective lower abdominal surgery. |
| Intervention |
Posterior transversus abdominis plane block |
After lower abdominal surgical procedure under spinal anaesthesia ultrasound-guided posterior transversus abdominis plane block single administration using 20 ml of 0.25% bupivacaine on bilateral side procedure duration approximately 5-10 minutes on each side deposited in the fascial plane between internal oblique and transversus abdominis muscle at the posterior axillary line in patients undergoing elective lower abdominal surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to give informed consent.
2. Patients of age 18-60 years.
3. ASA grade 1 and 2.
4. Patients with BMI 18.5 to 25.
5. Patients undergoing lower abdominal surgeries.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Patients with history of coagulopathy.
3. Patients with history of allergic to local anaesthetic.
4. Patients with severe systemic diseases.
5. Patient requiring postoperative mechanical ventilation.
6. Localized infection over injection point.
7. Duration of surgery more than 2 hours.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The post operative duration of analgesia.
2. Postoperative pain score VAS for 24 hours.
3. Need for rescue analgesia in first 24 hours.
4. Heamodynamic parameters like Heart rate, Blood pressure and SPO2.
5. Side effects including nausea and vomiting.
|
1.The post operative duration of analgesia.
2. Postoperative pain score VAS assessed at 30 minutes, 1hrs, 2hrs, 4hrs, 8hrs, 12hrs and 24hrs.
3. Need for rescue analgesia in first 24 hours.
4. Heamodynamic parameters like Heart rate, Blood pressure and SPO2 assessed at 30 minutes, 1hrs, 2hrs,4hrs,8hrs,12hrs and 24hrs.
5. Side effects including nausea and vomiting.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative requirement of rescue analgesia |
Post operative requirement of rescue analgesia assessed at 30 minutes,1hrs,2hrs,4hrs,8hrs,12hrs & 24hrs |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 3 |
|
Date of First Enrollment (India)
|
19/03/2026 |
| 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="1"
Months="0"
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
|
This study is designed to compare the duration of post operative analgesia in patients undergoing lower abdominal surgeries using posterior versus lateral transversus abdominis plane block techniques and minimize the use of post operative rescue analgesics and its associated side effects. |