| CTRI Number |
CTRI/2025/06/089372 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study in the effectiveness of Laproscopic Transversus Abdominis Plane block versus USG guided Erector Spinae Plane block in Laproscopic Upper GI surgeries |
|
Scientific Title of Study
|
A comparative study in the effectiveness of laproscopy guided tap block versus USG guided ESP block in laproscopic upper GI 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 |
Ayesha Nawaz Begum S |
| Designation |
Registrar |
| Affiliation |
Ruby Hall Clinic |
| Address |
Grant Medical Foundation,
Ruby Hall Clinic
40 , Sassoon road
Sangamwadi
Pune
MAHARASHTRA
411001
India |
| Phone |
8087183354 |
| Fax |
|
| Email |
ayeshnawaz1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kedar Patil |
| Designation |
Consultant |
| Affiliation |
Ruby Hall Clinic |
| Address |
Grant Medical Foundation,
Ruby Hall Clinic
40,Sassoon road
Sangamwadi
Pune
MAHARASHTRA
411001
India |
| Phone |
9823017515 |
| Fax |
|
| Email |
drkedarpatil09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kedar Patil |
| Designation |
consultant |
| Affiliation |
Ruby Hall Clinic |
| Address |
Grant Medical Foundation,
Ruby Hall Clinic
40,Sassoon road
Sangamwadi
Pune
MAHARASHTRA
411001
India |
| Phone |
9823017515 |
| Fax |
|
| Email |
drkedarpatil09@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ruby Hall Clinic |
| Address |
40,Sassoon Road
Sangamwadi
Pune
Maharashtra-411001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Kedar Patil |
Poona medical research foundation |
Grant Medical Foundation
Ruby Hall Clinic
40 ,Sassoon road
Sangamwadi
Pune
MAHARASHTRA |
9823017515
drkedarpatil9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| POONA MEDICAL RESEARCH FOUNDATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LAPROSCOPIC TRANSVERSUS ABDOMINIS PLANE BLOCK |
PROCEDURE TIME - 10-12 MINUTES
DURATION OF ACTION - 12 HOURS
Involves injecting local anesthetic in the plane between the transversus abdominis and internal oblique muscles. Provides somatic analgesia to the abdominal wall but lacks visceral analgesic effects. Targets the sensory nerves supplying the anterior abdominal wall. |
| Comparator Agent |
ULTRASOUND GUIDED ERECTOR SPINAE BLOCK |
PROCEDURE TIME - 20-30 MINUTES
DURATION OF ACTION - 12 HOURS
A paraspinal technique where local anesthetic is injected below the erector spinae muscles, targeting the dorsal and ventral rami of spinal nerves. Provides somatic analgesia and potentially visceral analgesia by blocking sympathetic rami communicans. Offers segmental analgesia for various surgical procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are over 18 years of Age.
2. Patients who have consented to undergo a Surgical and mode of analgesia in lap . General or Gastrointestinal Surgery(Cholecystectomy , hiatal hernia repairs , bariatric surgery ) and who were possessing full Mental Capacity of the events at the Institution.
3. Patients who have been discharged from the institution after undergoing a Surgical procedure at the institution.
4. Patients who have followed up with the Doctors of the institution after the Surgical procedure |
|
| ExclusionCriteria |
| Details |
1. Patients who are not Over 18 years of Age.
2. Patients who have not consented to undergo the Procedure at the Institution or did not possess full Mental Capacity of the events.
3.High risk patients , i.e risk of local bleeding , contaminated procedures,unstable physiology.
4. Patients who have not been discharged. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.comparative analysis of the analgesic effectiveness of Laproscopic TAP blocks versus USG-guided ESP blocks
2.Collect patient-reported outcomes to gauge the perceived effectiveness of both techniques in managing postoperative pain.
3.Investigate to reduce the need for opioid analgesics in the postoperative setting.
4.Use findings from the study to propose an optimized, evidence-based analgesia plan for the postoperative period |
1.on data collection completion
2. 6 hours and 12 hours post op
3. 24 hours in Immediate post op period
4 . After completion of sample size |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3.Investigate the potential for both techniques to reduce the need for opioid analgesics in the postoperative setting.
4.Use findings from the study to propose an optimized, evidence-based analgesia plan for the postoperative period that maximizes pain relief while minimizing opioid consumption.
|
3. ASSESED AT 6 HOURS TILL TIME OF DISCHARGE
4. END OF STUDY DATA COLLECTION |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/07/2025 |
| 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
|
This study compares the effectiveness of two regional anesthesia techniques—laparoscopic-guided Transversus Abdominis Plane (TAP) block and ultrasound-guided Erector Spinae Plane (ESP) block—in managing postoperative pain following upper abdominal laparoscopic surgeries (e.g., cholecystectomy, bariatric procedures).
A total of 50 adult patients were randomized into two groups (25 each). The study evaluates parameters such as pain relief, duration of analgesia, time to first analgesic request, and postoperative drug consumption, along with patient satisfaction, recovery milestones, and quality of life.
The aim is to identify which technique offers better pain control, reduces opioid use, and supports faster recovery, thereby optimizing postoperative care in line with Enhanced Recovery After Surgery (ERAS) protocols. |