| CTRI Number |
CTRI/2026/01/100403 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effect of adding two different drugs dexamethasone and magnesium sulfate with local anaesthetic ropivacaine 0.2% when infiltrated in the abdominal wall in providing pain relief in patient undergoing laparoscopic cholecystectomy |
|
Scientific Title of Study
|
USG guided subcostal TAP block with dexamethasone versus magnesium sulfate as adjuvants with ropivacaine 0.2% A prospective randomised controlled study in patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reshma B M |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
OT complex, 1st floor, Dr B R Ambedkar medical college and hospital, Kadugondanahalli, Bengaluru
Bangalore
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reshma B M |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
OT complex, 1st floor, Dr B R Ambedkar medical college and hospital, Kadugondanahalli, Bengaluru
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reshma B M |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
OT complex, 1st floor, Dr B R Ambedkar medical college and hospital, Kadugondanahalli, Bengaluru
KARNATAKA
560045
India |
| Phone |
8892019120 |
| Fax |
|
| Email |
lucky3276@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Reshma B M |
| Address |
OT complex, !st floor, Dr B R Ambedkar medical and hospital, kadugondanahalli, Bengaluru - 560045 |
| 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 Reshma B M |
Dr B R Ambedkar medical college and hospital |
OT complex, 1st floor, Dr B R Ambedkar medical college and hospital, Kadugondanahalli, Bengaluru - 560045
Bangalore
KARNATAKA |
8892019120
lucky3276@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION 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 |
| Comparator Agent |
Dexamethasone |
Addition of 8mg dexamethasone to 18ml of 0.2 percent ropivacaine each side for USG guided subcostal TAP block in patients undergoing laparoscopic cholecystectomy |
| Intervention |
Magnesium sulphate |
Addition of 200 mg magnesium sulphate to 18ml of 0.2 percent ropivacaine each side for USG guided subcostal TAP block in patients undergoing laparoscopic cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- Patients belonging to ASA PS 1 and 2
- Patients undergoing elective laproscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
- BMI more than 35kg/m2 and less than 18kg/m2
- Pregnancy and lactation
- Allergy to local anaesthetics and/or adjuvants
- Patients with severe cardiac disorders
- Patients refusal to participate in the study |
|
|
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 assess duration of postoperative analgesia in patients receiving subcostal TAP block with dexamethasone and magnesium sulfate as adjuvants with 0.2% ropivacaine |
2hrs, 4hrs, 8hrs, 12hrs, 18hrs, 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the VAS scores of all the patients receiving the subcostal TAP block with either adjuvants
2. To assess the adverse effects if any like bradycardia, hypotension, respiratory depression etc
3.To compare the haemodynamic parameters like heart rate, blood pressure, oxygen saturation.
4. To compare the patient satisfaction scores at the end of 24 hours |
2hrs, 4hrs, 8hrs, 12hrs, 18hrs,24hrs |
|
|
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)
|
20/01/2026 |
| 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
|
Laparoscopic cholecystectomy is one of the most commonly performed surgery. Subcostal TAP block is one of the effective methods of providing analgesia. In our study we compare the effect of two different adjuvants with 0.2% Ropivacaine in prolonging the duration of analgesia. After obtaining institutional ethical clearance and clinical trial registration, patients will be enrolled in the study. A thorough preanaesthetic evaluation will be done, based on inclusion and exclusion criteria patients will be selected and recruited after obtaining a written informed consent. Patients are grouped into 2 - Group A will receive 0.2% ropivacaine 18 ml with 8mg dexamethasone and Group B will receive 18ml 0.2% ropivacaine with 200mg magnesium sulfate on each side. Patient will be informed about the study protocol. Based on computer generated random numbers they are put into 2 group with allocation concealment via sealed envelopes that will be opened just before performing the block. Standard preanaesthesia protocol regarding nil per oral status and premedication will be followed. Induction and maintenance is based on standard anaesthesia practise of our hospital. After the completion of surgery patients are given USG guided subcostal TAP block based on the groups alloted. Patients are extubated and postoperatively followed up at 2, 4, 8, 12, 18 and 24 hours. Hemodynamic parameters, VAS scores, need for analgesia , side effects , PSS are noted. |