| CTRI Number |
CTRI/2025/04/085339 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of TAP Block and Intraperitoneal Ropivacaine for Pain Relief and Early Recovery After Laparoscopic Surgeries. |
|
Scientific Title of Study
|
Comparison of Tranversus Abdominis Plane (TAP) block with Intraperitoneal mist instillation using 0.5 % Isobaric Ropivacaine
in elective laparoscopic surgeries for postoperative pain management. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKUR SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Department of Anaesthesia, OT Complex, 2nd Floor, Main Hospital Building, Mahatma Gandhi University of Medical Sciences and Technology
Sitapura Tonk Road Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
7023345035 |
| Fax |
|
| Email |
ankursh@yandex.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sudhir Sachdev |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology
Sitapura Tonk Road Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829055666 |
| Fax |
|
| Email |
drvijaymathur9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANKUR SHARMA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Department of Anaesthesia, OT Complex, 2nd Floor, Main Hospital Building, Mahatma Gandhi University of Medical Sciences and Technology
Sitapura Tonk Road Jaipur Rajasthan India
Jaipur
RAJASTHAN
302022
India |
| Phone |
7023345035 |
| Fax |
|
| Email |
ankursh@yandex.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi University of Medical Sciences and Technology |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi University of Medical Sciences and Technology |
| Address |
Mahatma Gandhi University of Medical Sciences and Technology Sitapura Tonk Road Jaipur Rajasthan India |
| 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 |
| Ankur Sharma |
Mahatma Gandhi University of Medical Sciences and Technology |
Department of Anaesthesia, OT Complex, 2nd Floor, Main Hospital Building, Mahatma Gandhi University of Medical Sciences and Technology
Sitapura Tonk Road Jaipur Rajasthan India
Jaipur
RAJASTHAN |
7023345035
ankursh@yandex.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Institutional Ethics Committee, Mahatma Gandhi Medical Medical College and 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 |
Intraperitoneal Mist Instillation |
Intraperitoneal mist instillation with Ropivacaine 0.5% 20ml using the Aerogen Pro® device. |
| Intervention |
Tranversus Abdominis Plane (TAP) Block. |
Ultrasound guided bilateral Transversus Abdominis Plane Block will be administered to the patients after surgery using Ropivacaine 0.5% 10ml on each side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient posted for elective abdominal laparoscopic surgery needing general anaesthesia.
Patient with American Society of anaesthesiologists (ASA) Class I and II |
|
| ExclusionCriteria |
| Details |
BMI more than 35
Patient with known or newly diagnosed coagulopathy
Patient with history of drug allergy.
More than one attempt at T.A.P. blockade |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of analgesia between Transversus Abdominis Plane Block (TAP) Block and Intraperitoneal mist instillation of Ropivacaine by assessing post-operative pain (static and dynamic) as per Numeric Rating Scale (NRS). |
Postoperative pain score (NRS), SBP, DBP, MAP, HR and Oxygen Saturation will be recorded at 0 hours, 2 hours, 6 hours,12 hours and 24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the meantime of the first dose of rescue analgesia in either group & the total supplementary analgesia required.
2. Assessment of early recovery profile & ambulation as per ERAS protocol. |
Postoperative pain score will be recorded at 0 hours 2 hours 6 hours 12 hours & 24 hours after surgery & time taken for first dose of rescue analgesia postoperatively |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
06/05/2025 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a prospective, hospital based, comparative study to compare the efficacy of analgesia between Transversus Abdominis Plane Block (TAP) Block and Intraperitoneal mist instillation of Ropivacaine by assessing post-operative pain (static and dynamic) as per Numeric Rating Scale (NRS). The secondary objective is to compare the meantime of the first dose of rescue analgesia in either group and the total supplementary analgesia required. Assessment of early recovery profile and ambulation as per ERAS protocol and to observe adverse effect related to study drug, if any. |