| CTRI Number |
CTRI/2026/03/106848 [Registered on: 24/03/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Two different dose regimens of duloxetine comparision on laproscopic cholecystectomy patients |
|
Scientific Title of Study
|
Evaluation of two different dose regimens of preoperative Duloxetine on Postoperative Pain After laparoscopic cholecystectomy: Randomized Controlled 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 |
Keerthan k p |
| Designation |
Junior resident |
| Affiliation |
shri B M Patil medical college, hospital and research centre, vijayapura |
| Address |
Department of anesthesiology, 3rd floor, shri B M Patil medical
college, hospital and research centre, vijayapura, Karnataka , India
Bijapur
KARNATAKA
586103
India
Bijapur
KARNATAKA
586103
India |
| Phone |
7019606646 |
| Fax |
|
| Email |
keerthankp0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Renuka Holayachi |
| Designation |
Professor, Head of the Department of Anaesthesiology |
| Affiliation |
Shri B.M. Patil Medical College, Hospital & Research Centre Vijayapur, Karnataka |
| Address |
Professor, HOD
Department of Anaesthesiology
B.L.D.E.
Shri B.M. Patil Medical College, Hospital & Research Centre
Vijayapur, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9886492178 |
| Fax |
|
| Email |
renuka312@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr keerthan k p |
| Designation |
Junior resident department Department of Anaesthesiology |
| Affiliation |
Shri B.M. Patil Medical College, Hospital & Research Centre Vijayapur, Karnataka |
| Address |
Junior resident
Department of Anaesthesiology
B.L.D.E.
Shri B.M. Patil Medical College, Hospital & Research Centre
Vijayapur, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
7019606646 |
| Fax |
|
| Email |
Keerthankp0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr keerthan k p Department of Anaesthesiology
B.L.D.E.
Shri B.M. Patil Medical College, Hospital & Research Centre
Vijayapur, Karnataka 586103 |
|
|
Primary Sponsor
|
| Name |
keerthan k p |
| Address |
Department of anesthesiology, 3rd floor, shri B M Patil medical
college, hospital and research centre, vijayapura, Karnataka , India
Bijapur
KARNATAKA
586103
India |
| 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 |
| Keerthan k p |
Shri b m Patil medical college hospital and research centre |
Department of anesthesiology, 3rd floor, shri B M Patil medical
college, hospital and research centre, vijayapura, Karnataka , India
Bijapur
KARNATAKA
586103
India
Bijapur
KARNATAKA |
7019606646
Keerthankp0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE ( deemed to be university) institutional ethics committee |
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 |
Tab duloxetine |
Patients were randomly assigned into two groups Group A received duloxetine 30 mg the night before surgery and 30 mg two hours before surgery All doses were given orally with a small amount of water |
| Comparator Agent |
Tab Duloxetine |
Patients were randomly assigned into two groups. Group B received duloxetine 30 mg the night before surgery and 60 mg two hours before surgery All doses were given orally with a small amount of water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing laparoscopic cholecystectomy.
• Patients belonging to ASA grade 1 and 2
• BMI 18- 24 kg/m2 |
|
| ExclusionCriteria |
| Details |
Liver or renal dysfunction
Daily corticosteroid use
History of duloxetine allergy
Patients with cognitive psychological or communication disorders
Patient with uncontrolled DM HTN and IHD
Pregnant or nursing women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to First Analgesic Requirement postoperatively |
2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pressor response during intubation after administration of duloxetine preoperatively |
1 minute, 3 minutes, 5 minutes, 10 minutes, & 15 minutes after the induction of anesthesia |
| Comparison of postoperative shoulder pain in two groups |
2 hours, 4 hours, 8 hours, 12 hours 24 hours postoperatively |
| Assessment of Adverse Events: ponv, shivering, urinary retention, sedation, & other adverse events if any |
2 hours, 4 hours, 8 hours, 12 hours 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
15/04/2026 |
| 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 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
|
This study is a prospective randomized double blind trial involving 122 patients undergoing elective cholecystectomy under general anesthesia Patients are randomly divided into two groups of 61 each using a computer generated sequence with allocation concealed in sealed envelopes opened by a pharmacist not involved in the study Group A receives duloxetine 30 mg the night before surgery and 30 mg two hours before surgery Group B receives 30 mg the night before and 60 mg two hours before surgery Both are given with small amounts of water All patients receive standard premedication with ondansetron midazolam and glycopyrrolate Standard monitoring is applied and anesthesia is induced with fentanyl propofol and vecuronium followed by endotracheal intubation and mechanical ventilation using oxygen nitrous oxide and isoflurane Hemodynamic parameters are recorded at regular intervals after induction At the end of surgery residual carbon dioxide is removed and neuromuscular blockade is reversed No additional intraoperative analgesics are given Duration of surgery is recorded Postoperatively patients are monitored in the recovery unit Pain is assessed using the visual analogue scale at 2 4 8 12 and 24 hours and shoulder pain is assessed using a numeric rating scale Rescue analgesia with intravenous acetaminophen is given if pain score is 4 or more All data including drug doses clinical parameters and patient responses are recorded for analysis |