| CTRI Number |
CTRI/2021/06/034291 [Registered on: 17/06/2021] Trial Registered Prospectively |
| Last Modified On: |
15/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Postoperative Pain Management in laparoscopic cholecystectomy patients using Duloxetine |
|
Scientific Title of Study
|
Evaluating the effect of Duloxetine premedication on postoperative analgesic requirement in patients undergoing laparoscopic cholecystectomy surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivika Nath |
| Designation |
Assistant Professor |
| Affiliation |
School of Medical Sciences & Research |
| Address |
Department of Anesthesiology School of Medical Sciences & Research Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9999096812 |
| Fax |
|
| Email |
doc.shivi45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivika Nath |
| Designation |
Assistant Professor |
| Affiliation |
School of Medical Sciences & Research |
| Address |
Department of Anesthesiology School of Medical Sciences & Research Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9999096812 |
| Fax |
|
| Email |
doc.shivi45@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambhrin Saha |
| Designation |
PGT |
| Affiliation |
School of Medical Sciences & Research |
| Address |
Department of Anesthesiology School of Medical Sciences & Research Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9774713651 |
| Fax |
|
| Email |
ambhrin.saha@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology School of medical sciences and research |
|
|
Primary Sponsor
|
| Name |
Sharda Hospital School of Medical Sciences Research |
| Address |
School of medical sciences & research, Greater Noida |
| Type of Sponsor |
Private medical college |
|
|
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 Ambhrin Saha |
Sharda Hospital, School of Medical Sciences & Research |
Department of Anesthesiology School of Medical Sciences & Research
Gautam Buddha Nagar
UTTAR PRADESH |
9774713651
ambhrin.saha@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, School of Medical Sciences & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Capsule Becosule |
Capsule Becosule(std dose) will be used as placebo, as it looks similar to our primary drug. One capsule will be given per orally as Stat dose, 2 hours prior to laparoscopic cholecystectomy surgery. Patient will be chosen as per randomisation. Drug wont be repeated. |
| Intervention |
Capsule Duloxetine 60mg |
Capsule Duloxetine 60 mg Stat dose per orally, will be given 2 hours prior to laparoscopic cholecystectomy operation for better analgesia.Patient will be chosen as per randomisation. It wont be repeated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. All the elective cases of Laparoscopic Cholecystectomy of ASA I or II,
scheduled for general anesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Patients with any known history of cardiovascular diseases 3.Patients with known case of hepatic and renal disease
4.Patients with known history of substance abuse
5.A chronic opioid abuser(>3 months), being on chronic Gabapentin or Pregabalin(>3months)
6.Patients on antidepressant drugs and patients with psychiatric disorders 7.Anticipitated difficult airway on preoperative assessment 8.Patients converted to open cholecystectomy from laparoscopic cholecystectomy
9. Patients in whom drain placement has been done 10.BMI>30
11.Pregnant and lactating females
12.History of allergy to any of the drug to be administered |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the analgesic efficacy of duloxetine premedication on post operative analgesic requirement in laparoscopic cholecystectomies using VAS score(Visual Analogue Scale) |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Total dose of first and second rescue analgesic (InjParacetamol&InjTramadol) consumption in post operative period.
b) Ramsey Sedation Score in Preoperative & postoperative period
c) Hemodynamic changes
d) Demographic data
e) Incidence of side effects (if any) |
12 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/06/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
.Despite recent advances in minimal invasive surgery, postoperative pain control
remains a challenge for both surgeons and anesthesiologists and plays an important
role in accelerating the improvement of surgical patients’ general condition. The
laparoscopy technique is a revolutionary in surgical field, presenting several
advantages such as smaller surgical incisions, less bleeding, shorter hospitalization
time, and lower hospital costs. However, postoperative pain is still a complication that
results in an unpleasant experience and delayed discharge.
Considering the benefits of the thiophene derivative ‘Duloxetine’ in suppressing the postoperative pain response, we will be supplementing our general anesthesia technique with preoperative Duloxetine supplementation anticipating better postoperative pain status of patients undergoing laparoscopic cholecystectomy in the perioperative period and comparing with the control group where the conventional protocols of general anaesthesia & pain management will be followed. |