| CTRI Number |
CTRI/2026/02/104190 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
BA/BE |
|
Type of Study
|
Randomized control trial |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study checks whether adding morphine to a local anesthetic injection before laparoscopic gallbladder removal surgery patients to see which gives better pain control during and after surgery |
|
Scientific Title of Study
|
A comparative study of the effect of addition of morphine to ropivacaine and ropivacaine alone for preemptive transverse abdominis plane block on the perioperative analgesia on patients undergoing laparoscopic cholecystectomy -a randomized control trial |
| 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 Aravindu |
| Designation |
Post graduate |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Door no 30 Jaraka bande forest quaters Kammagondanahalli Jalahalli west Bangalore 560015
Bangalore
KARNATAKA
560015
India |
| Phone |
9535481142 |
| Fax |
|
| Email |
dr.aravindu7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya shukla |
| Designation |
Assistant professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
BMCRI superspeciality hospital fort K R road Bangalore 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9945659167 |
| Fax |
|
| Email |
divyashukla17sep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aravindu |
| Designation |
Post graduate |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Door no 30 Jaraka bande forest quaters Kammagondanahalli Jalahalli west Bangalore 560015
Bangalore
KARNATAKA
560015
India |
| Phone |
9535481142 |
| Fax |
|
| Email |
dr.aravindu7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aravindu |
| Address |
Door no 30 Jaraka Bande Forest quaters Kammagondanahalli Jalahalli west Bangalore 560015 |
| 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 Aravindu |
Bangalore medical college and attached hospitals |
Department of Anaesthesiology,MPB 3rd floor K R road Fort Bangalore 560002
Bangalore
KARNATAKA |
9535481142
dr.aravindu7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine |
20cc of 0.2% of ropivacaine with 3cc of normal saline given in transverse abdominis plane block
The study conducted for the duration of 1 year 7 months |
| Intervention |
Ropivacaine with morphine |
20cc of 0.2% ropivacaine with morphine 0.05mg/kg body weight given in transverse abdominis plane block
The study conducted for the duration of 1 year 7 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give informed consent
ASA grade 1
Patients with BMI 18.5-25
Patients undergoing laparoscopic cholecystectomy surgeries lasting less than 4 hours |
|
| ExclusionCriteria |
| Details |
Patients refusal
Patients with history of coagulopathy
Patients with history of allergic to local anaesthetic
Patients with severe systemic disease
Psychiatric illness
Chronic medication taking for pain
Patients requiring postoperative mechanical ventilation
Localized infection over injection point
Technical failure |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analogue score |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the time to first rescue analgesia & number of doses of rescue analgesia |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/03/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-03-2026 and end date provided 02-03-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A comparative study of the effect of addition of morphine to ropivacaine and ropivacaine alone for preemptive transverse abdominis plane block on the peri operative analgesia on patients undergoing laparoscopic cholecystectomy is a double blinded randomized control trial The primary outcome to assess analgesic efficacy with respect to VAS score and the secondary outcome to assess the intraoperative total opioid consumption and to assess intraoperative hemodynamic changes and to assess time for the first rescue analgesia and total number of doses of rescue analgesia in 24 hours Study will be conducted in Bangalore medical college attached hospitals with sample size of 40 Duration of study is from July 2025 to December 2026 |