| CTRI Number |
CTRI/2025/06/088525 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of the effect of duloxetine and pregabalin on analgesic requirement after gynecologic laparoscopic surgery |
|
Scientific Title of Study
|
Comparative study of duloxetine and pregabalin on postoperative analgesic requirement following laparoscopic gynecological surgeries: A prospective, randomized, double blind and placebo-controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHB/CR/30/05-05-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sabyasachi Pradhan |
| Designation |
DNB Student |
| Affiliation |
Apollo Hospitals Bilaspur (C.G.) |
| Address |
Department of Anesthesia, Second floor, OT Complex, Apollo Hospitals Bilaspur, Seepat Road, Lingiadih village
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
8637295026 |
| Fax |
|
| Email |
pradhansabyasachi24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anesthesia, Second floor, OT Complex, Apollo
Hospitals Bilaspur, Seepat Road, Lingiadih village
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinit Kumar Srivastava |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Hospitals Bilaspur |
| Address |
Department of Anesthesia, Second floor, OT Complex, Apollo
Hospitals Bilaspur, Seepat Road, Lingiadih village
Bilaspur
Bilaspur
CHHATTISGARH
495006
India |
| Phone |
9755557539 |
| Fax |
|
| Email |
drvinit75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals Bilaspur, Seepat Road, Lingiadih village (C.G.) India
Pin 495006 |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Bilaspur |
| Address |
Seepat road Lingiadih village, Bilaspur Chhattisgarh, India
Pin 495006 |
| 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 Sabyasachi Pradhan |
Apollo Hospitals Bilaspur |
OT Complex Second floor, OT No -2
Seepat Road, Lingiadih village
Bilaspur
CHHATTISGARH |
8637295026
pradhansabyasachi24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Apollo Hospitals Bilaspur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Duloxetine |
Duloxetine 60 mg 2 hour before surgery |
| Comparator Agent |
Placebo capsule |
Placebo capsule 2 hour before surgery |
| Intervention |
Pregabalin |
Pregabalin 150 mg 2 hour before surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade I and II
2. Scheduled for laparoscopic gynecological surgery under general anesthesia |
|
| ExclusionCriteria |
| Details |
1. Known allergy to study drugs
2. History of PONV
3. Use of antiemetic drug within 24 hour of surgery
4. Morbid obesity (BMI.40)
5. Patient with history of hepatic, renal and cardiovascular dysfunction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fentanyl requirements
|
Within 24 hours after surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS score at rest and on movement, adverse effects of study drugs (headache, nausea, vomiting, dry mouth, urinary retention, ileus, urticaria, hypotension, bradycardia, respiratory depression, itching), sedation score and patient satisfaction score.
|
Within 24 hours after surgery surgery |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| 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) |
Open to Recruitment |
|
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
|
Postoperative pain control is one of the main issues that plays a crucial role in hastening patients’ general condition improvement. Laparoscopic surgeries have many advantages over open surgery, such as smaller incisions, lower morbidity, rapid recovery, and reduction in hospital stays. However, a significant number of patients after laparoscopic surgeries still suffer from high levels of pain and require pain relief, with PONV being the second most common complaint. Duloxetine is a selective antidepressant that inhibits serotonin and noradrenaline reuptake in the central nervous system. Pregabalin is a structural analog of GABA and is an anticonvulsant drug that selectively affects pain transmission. Both drugs reduce acute pain and postoperative opioid consumption following some surgeries. Hence, the present study will be carried out to compare the postoperative analgesic efficacy of duloxetine and pregabalin in laparoscopic surgery. All selected patients will be randomized into 3 study groups (30 patients in each group)
Group D - Patients will receive duloxetine 60 mg, 2 hours before surgery Group P - Patients will receive pregabalin 150 mg, 2 hours before surgery Group C - Patients will receive similar-looking placebo 2 hours before surgery
Primary outcome - Total fentanyl requirements within 24 hours after surgery Secondary outcome - VAS score at rest and on movement, adverse effects of study drugs (nausea, vomiting, dry mouth, urinary retention, ileus, urticaria, hypotension, bradycardia, respiratory depression, itching), sedation score, and patient satisfaction score.
Statistical analysis will be done after the completion of study |