| CTRI Number |
CTRI/2025/07/091725 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the use of M - TAPA Nerve block for reducing pain after Laparoscopic Cholecystectomy |
|
Scientific Title of Study
|
EFFICACY OF PREEMPTIVE ULTRASOUND - GUIDED MODIFIED THORACOABDOMINAL NERVE BLOCK THROUGH PERICHONDRIAL APPROACH (M -TAPA) FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA. |
| 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 Rekha S |
| Designation |
Post Graduate |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura Main road Kadugondanahalli Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9113295376 |
| Fax |
|
| Email |
appirekha5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Vijaykumar Kadlimatti |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9008229914 |
| Fax |
|
| Email |
deepakkadlimatti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rekha S |
| Designation |
Post Graduate |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9113295376 |
| Fax |
|
| Email |
appirekha5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar medical college and hospital Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Rekha S |
| Address |
Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Bangalore Karnataka India 560045 |
| Type of Sponsor |
Other [] |
|
|
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 Rekha S |
Dr B R Ambedkar medical college and hospital |
Department of Anaesthesiology 1st floor Shampura main road Kadugondanahalli Bangalore 560045 Bangalore KARNATAKA |
9113295376
appirekha5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Modified Thoracoabdominal nerve block through perichondrial approach |
Patients posted for elective laparoscopic cholecystectomy will be given preemptive ultrasound guided bilateral modified thoracoabdominal nerve block through perichondrial approach using Inj Bupivacaine 0.25% 20ml with Inj Dexamethasone 4mg |
| Comparator Agent |
Not appicable |
Not applicable. Single arm interventional study. No comparator used. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective laparoscopic cholecystectomy under general anaesthesia 2. Patients aged between 18 to 75y 3. Patients belonging to American Society of Anaesthesiologists Physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Known allergy to the local anaesthetics given.
2. Patients with chronic pain on slow-release preparations of opioid, drug or alcohol abuse.
3. Patients with dementia or cognitive problems.
4. Patients with BMI greater than 35kg/m2.
5. Coagulopathy or patients on anti-coagulants
6. Known case of Diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of postoperative analgesia following laparoscopic cholecystectomy |
For first 24 postoperative hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate analgesic consumption in first 24 postoperative hours.
To assess the incidence of adverse effects like nausea, vomiting. |
FROM THE TIME OF BLOCK UPTO 24H AFTER THE BLOCK |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
04/08/2025 |
| 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="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
|
Laparoscopic cholecystectomy brings benefits such as less pain, shorter hospital stay, and earlier recovery, and it is a cost-effective procedure. Though it is known for its minimally invasive nature, postoperative pain management remains challenging. Poorly controlled early postoperative pain impairs the quality of recovery, increasing the risk of postoperative pulmonary complications. It was observed that the abdominal pain following Laparoscopic cholecystectomy mostly originates from the incision area, and the remaining part consists of visceral and referred pain. Among various regional techniques, the subcostal transversus abdominis plane block is a regional analgesic technique that can provide analgesia of the supraumbilical abdomen and has showed greatest reduction in pain score at 12hours postoperatively compared with other regional analgesic techniques. Modified Thoracoabdominal nerve block through perichondrial approach, which administers local anaesthetics only between the costal cartilage and the transverse abdominis muscle which provides wide blockage area that includes T5 and T11 to T12 dermatomal levels because the applied local anaesthetics also passes the linea semilunaris. It also has an advantage of performing the block in supine position In this background the research question of the present study is to assess the duration of postoperative analgesia following laparoscopic cholecystectomy using Inj Bupivacaine 0.25 percent. |