| CTRI Number |
CTRI/2025/02/081331 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Post operative Pain Relief by blocking nerves causing pain in Patients Undergoing Laparoscopic Gallbladder removal Surgery by an Imaging technique like USG Guided without making injury to near by structures |
|
Scientific Title of Study
|
Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy |
| 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.R.Sathiyamoorthy |
| Designation |
Post graduate student |
| Affiliation |
Institute of Anaesthesiology,Government Rajaji Hospitals & Madurai medical college,Madurai |
| Address |
4/23 Sappani kovil Street,
mathisiyam,Goripalayam,
Madurai-625020
Room No 121,Institute of Anaesthesiology,
Anaesthesia Division,Government Rajaji Hospitals & Madurai medical college,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9944403392 |
| Fax |
|
| Email |
ravisathya93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.S.Pratheeba durairaj MD DA |
| Designation |
Professor |
| Affiliation |
Institute of Anaesthesiology,Government Rajaji Hospitals & Madurai medical college,Madurai |
| Address |
24,Ponmani narayanan street,SS Colony,Madurai,16
Room No 121,Institute of Anaesthesiology,
Anaesthesia Division,Government Rajaji Hospitals & Madurai medical college,Madurai
Madurai
TAMIL NADU
625016
India |
| Phone |
9443183984 |
| Fax |
|
| Email |
rajdeep181069@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.R.Sathiyamoorthy |
| Designation |
Post graduate student |
| Affiliation |
Institute of Anaesthesiology,Government Rajaji Hospitals & Madurai medical college,Madurai |
| Address |
No 121,Institute of Anaesthesiology,Government Rajaji Hospitals & Madurai medical college,Madurai
No 121,Institute of Anaesthesiology,Government Rajaji Hospitals & Madurai medical college,Madurai
Madurai
TAMIL NADU
625020
India |
| Phone |
9944403392 |
| Fax |
|
| Email |
ravisathya93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Anaesthesiology,Government Rajaji Hospitals & Madurai medical college,Madurai-625020,Tamilnadu,India |
|
|
Primary Sponsor
|
| Name |
DrRSathiyamoorthy |
| Address |
Institute of Anaesthesiology,Government Rajaji Hospitals & Madurai medical college,Madurai 625020 Tamilnadu , India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrRSathiyamoorthy |
Government Rajaji Hospitals & Madurai medical college,Madurai |
Room no 1,Ssb block,Surgical Gastroenterology Operation Theatre,
Institute of Anesthesiology, Govt Rajaji Hospital & Madurai Medical College, Madurai
Madurai
TAMIL NADU |
9944403392
ravisathya93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,Government Rajaji Hospital & Madurai medical college,Madurai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy-[Nil] |
Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy
Dose-0.25 % Bupivacaine 25 ml in both side in plane approach Total duration of procedure 10 minutes in both side |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 &ASA 2 PATIENTS,THOSE WHO WILLING TO GIVE INFORMED WRITTEN CONSENT |
|
| ExclusionCriteria |
| Details |
1. Coagulation disorders.
2. Infection at the injection site.
3. Known allergy to local anesthetics (LA).
4. Advanced liver or kidney failure.
5. History of abdominal surgery or trauma.
6. Conversion to open surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the post operative analgesic efficacy following nerve block |
To determine the duration post operative analgesia in first 24 hrs of Post operative period at a interval period of 2 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assess the use of rescue analgesia.
2. Intraoperative opioid usage.
3. Intraoperative hemodynamic status—pulse rate, BP, and respiratory rate.
4. Post-operative respiratory rate and SpO2.
5. Complications like pneumothorax, local anesthetic toxicity, vascular injury.
6. Post-operative nausea and vomiting ( |
In first 24 hrs after surgery |
|
|
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)
|
05/03/2025 |
| 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="0"
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
|
Laparoscopic cholecystectomy is described as a minimally invasive and cost-effective procedure with several benefits, such as:
Less pain,
Shorter hospital stay, and
Faster recovery.
However, it can still cause moderate to severe post-operative pain, which is a critical concern. Pain has multiple sources, including visceral pain and referred shoulder pain, along with incisional pain. To manage this, various methods are employed, including:
Nonsteroidal anti-inflammatory drugs (NSAIDs),
Paracetamol,
Opioids,
Local anesthetics, and
Regional anesthesia techniques.
Several regional anesthesia techniques are mentioned, including:
Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and
Serratus Intercostal Plane Block (SIP), which are effectiv… |