| CTRI Number |
CTRI/2026/02/103636 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see which pain killer helps patient feel more comfortable after surgery |
|
Scientific Title of Study
|
Comparison of IV Fentanyl and IV Morphine and assessment of quality of recovery following general anaesthesia in patients under going laparoscopic abdominal surgery using QoR-15 observational study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwini |
| Designation |
Post graduate |
| Affiliation |
Dr BR Ambhedkar medical college and hospital |
| Address |
Department of Anaesthesiology
DR BR AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, Kadugondanahalli
Bangalore
KARNATAKA
560045
India |
| Phone |
7206304708 |
| Fax |
|
| Email |
ashwinimalik0813@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Bhadri Narayan |
| Designation |
Post Graduate |
| Affiliation |
Dr BR Ambhedkar medical college and hospital |
| Address |
Major OT complex
Department of anaesthesiology
Dr BR Ambedkar medical college and hospital Kadugondanahalli
Bangalore
KARNATAKA
560045
India |
| Phone |
9448084257 |
| Fax |
|
| Email |
bhadrinimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Bhadri Narayan |
| Designation |
Post Graduate |
| Affiliation |
Dr BR Ambhedkar medical college and hospital |
| Address |
Major OT Complex
Department of Anaesthesiology
Dr BR Ambhedkar Medical College and Hospital Kadugondanahalli
Bangalore
KARNATAKA
560045
India |
| Phone |
9448084257 |
| Fax |
|
| Email |
bhadrinimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Major OT Complex
Department of Anaesthesiology
Dr BR Ambhedkar Medical College and Hospital Kadugondanahalli
560045 |
|
|
Primary Sponsor
|
| Name |
Dr BR Ambhedkar Medical College and Hospital |
| Address |
Major OT Complex
Department of Anaesthesiology
Dr BR Ambhedkar Medical College and Hospital Kadugondanahalli,
560045
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 ASHWINI |
Major OT Complex DEPARTMENT OF ANAESTHESIA |
BR AMBEDKAR MEDICAL COLLEGE AND HOSPITAL , KADUGONDAHALLI , BENGALURU - 560045
Bangalore
KARNATAKA |
07206304708
ashwinimalik0813@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (4) ICD-10 Condition: K40-K46||Hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective laparoscopic abdominal surgery under general anaesthesia
2. Age 18-65 years
3. American Society of Anaesthesiologist (ASA1 and ASA2) |
|
| ExclusionCriteria |
| Details |
1. Patients refusal
2. Bleeding or coagulation abnormality
3. Allergic to drugs
4. Pregnancy
5. Previous surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the quality of recovery using QoR-15 (Quality of recovery-15 questionnaire) |
Checked at 24 and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assess the analgesia requirements postoperatively after 24 and 48 hour respectively
2. Assess the analgesia requirement in different genders |
Checked at 24 and 48 hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/03/2026 |
| 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 - NO
|
|
Brief Summary
|
Laparoscopic surgery is widely used for many abdominal procedures because it is minimally invasive. Recovery after surgery depends on patient, surgical, and anaesthetic factors. Most studies assess recovery using clinical outcomes such as complications and recovery time, but these do not reflect the patient’s experience. The Quality of Recovery-15 (QoR-15) questionnaire is a simple tool that measures recovery from the patient’s perspective. It includes 15 questions covering pain, physical comfort, physical independence, psychological support, and emotional state. Scores range from 0 to 150, with higher scores indicating better recovery. A change of 8 points is considered clinically meaningful. |