| CTRI Number |
CTRI/2024/12/078005 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparison between ultrasound guided modified thoracoabdominal perichondrial approach nerve block versus oblique subcostal transverse abdominis plane block. |
|
Scientific Title of Study
|
To compare the postoperative analgesia between ultrasound guided modified thoracoabdominal nerve block through perichondrial approach versus oblique subcostal transabdominal plane block for patients undergoing laparoscopic cholecystectomy: a randomised study. |
| 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 Sohail Hasan Laskar |
| Designation |
Post Graduate Trainee |
| Affiliation |
gauhati medical college and hospital |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati medical college and hospital.
bhangagarh guwahati
Kamrup
ASSAM
781032
India |
| Phone |
7575916541 |
| Fax |
|
| Email |
sohailhasan0712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Faiza Ahmed Talukdar |
| Designation |
Professor and Head of Department |
| Affiliation |
Gauhati medical college and hospital |
| Address |
department of anesthesiology and critical care
bhangagarh guwahati
Kamrup
ASSAM
781032
India |
| Phone |
9864031429 |
| Fax |
|
| Email |
faizaahmedtalukdar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohail Hasan Laskar |
| Designation |
Post Graduate Trainee |
| Affiliation |
gauhati medical college and hospital |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati medical college and hospital.
bhangagarh guwahati
Kamrup
ASSAM
781032
India |
| Phone |
7575916541 |
| Fax |
|
| Email |
sohailhasan0712@gmail.com |
|
|
Source of Monetary or Material Support
|
| GAUHATI MEDICAL COLLEGE AND HOSPITAL, BHANGAGARH, GUWAHATI, KAMRUP METRO, PIN 781032, ASSAM |
|
|
Primary Sponsor
|
| Name |
Dr SOHAIL HASAN LASKAR |
| Address |
Department of Anaesthesiology and Critical Care
Gauhati medical college and hospital, Guwahati,
Assam.
PIN- 781032 |
| 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 |
| Dr Sohail Hasan Laskar |
gauhati medical college and hospital |
Department of Anaesthesiology and Critical Care
Gauhati medical college and hospital.
Kamrup
ASSAM |
7575916541
sohailhasan0712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gauhati 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 |
| Intervention |
USG guided modified thoracoabdominal perichondrial approach nerve block |
25 ml of ropivacaine 0.2% injected bilaterally 15 minutes before skin incision and will be assessed till 24 hours postoperatively. |
| Comparator Agent |
USG guided oblique subcostal transversus abdominis plane nerve block |
25 ml of ropivacaine 0.2% injected bilaterally 15 minutes before skin incision and will be assessed till 24 hours postoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the American Society of Anaesthesiologists (ASA) grading I and II
Patients posted for elective laparoscopic cholecystectomy under general anaesthesia.
Availability of informed and written consent from the patient party.
|
|
| ExclusionCriteria |
| Details |
BMI more than 35 kg per m² at the time of the surgery.
Patient weighing less than 34kg at the time of surgery.
History of allergy to any local anaesthetic.
Patients having coagulopathy or bleeding disorder are to be excluded.
Patients having infection at the site of block are to be excluded.
Patients having neurological deficits or on analgesic for chronic pain.
Patients having neuropsychiatric disorders hearing impairment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia between the two groups in the first 24 postoperative hours. |
To compare the duration of analgesia between the two groups
at 0 min,
at 15 mins,
at 30 mins,
at 60 mins,
at 6 hours,
at 12 hours and
at 24 hours
time intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the total analgesic requirements between the two groups in the first 24 postoperative hours.
|
Within 24 hours. |
| To compare the NRS pain scores between two groups at rest & at motion. |
At 0 min,
at 15 mins,
at 30 mins,
at 60 mins,
at 6 hours,
at 12 hour and
at 24 hours.
|
| Presence of post-operative shoulder pain postoperatively. (Yes/No) |
Within 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
26/12/2024 |
| 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)
Modification(s)
|
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
|
In this study we try to compare the post operative analgesic ability of USG guided modified thoracoabdominal nerve block via perichondrial approach with the USG guided oblique subcostal transversus abdominis plane block using ropivacaine 0.2% in patients who are undergoing laparoscopic cholecystectomy within the inclusion criteria limits. |