| CTRI Number |
CTRI/2025/10/096004 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| 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 Two Pain Relief Medicines Pregabalin and Gabapentin in Patients Undergoing Lower Abdominal Surgery with Spinal Anaesthesia |
|
Scientific Title of Study
|
Pregabalin and Gabapentin as preemptive analgesia in lower abdominal surgeries performed under spinal anaesthesia - A comparative study |
| 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 Kiran |
| Designation |
Resident Anesthesiology |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care, Third Floor, Pacific Medical College and hospital, Bilo ka Bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8351985740 |
| Fax |
|
| Email |
NK21595@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Goyal |
| Designation |
Professor of Anaesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care, Third Floor, Pacific Medical College and hospital, Bilo ka Bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890802830 |
| Fax |
|
| Email |
sameergoy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sameer Goyal |
| Designation |
Professor of Anaesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department of Anesthesiology and Critical Care, Third Floor, Pacific Medical College and hospital, Bilo ka Bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
8890802830 |
| Fax |
|
| Email |
sameergoy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, Third Floor, Pacific Medical College and hospital, Udaipur, Rajasthan
Pincode 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital, Udaipur |
| Address |
Department of Anesthesiology and Critical Care, Third Floor, Pacific Medical College and hospital, Bilo ka Bedla, Udaipur, Rajasthan
Pincode 313001 |
| 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 Kiran |
Pacific Medical College and Hospital |
Department of Anesthesiology and Critical Care, Third Floor, Pacific Medical College and hospital, Bilo ka Bedla, Udaipur, Rajasthan
Pincode 313001
Udaipur
RAJASTHAN |
08351985740
NK21595@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Commitee Pacific Medical College and Hospital Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: N800||Endometriosis of uterus, (3) ICD-10 Condition: N819||Female genital prolapse, unspecified, (4) ICD-10 Condition: N950||Postmenopausal bleeding, (5) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (6) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (7) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (8) ICD-10 Condition: N926||Irregular menstruation, unspecified, (9) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cap Pregabalin (200mg), Cap Gabapentin (600mg) and placebo (2 capsules) |
To give Cap Pregabalin (2 capsules of 100mg) or Cap gabapentin (2 capsules of 300mg) or placebo (2 capsules) 1 hour before surgery |
| Intervention |
Spinal Anaesthesia |
Use of 15mg of Inj Bupivacaine 0.5% hyperbaric after free flow of CSF |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with informed consent.
Adult patients aged between 20 and 60 years.
Patients of ASA grade I and II.
Patients undergoing elective lower abdominal surgeries under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient giving negative consent.
Patient planned for emergency surgeries.
Patient allergic to gabapentoids.
Pregnant or lactating females.
Patient with a known history of hepatic, renal, haematological, neuromuscular, cardiovascular disorders. |
|
|
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 |
| Improved postoperative pain control. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparative efficacy of gabapentoids in term of duration of analgesia and pain intensity (VAS score) |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
20/10/2025 |
| 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 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
|
Prospective, double - blind, randomised comparative study to compare the analgesic efficacy of pregabalin and gabapentin as preemptive analgesia in patients undergoing lower abdominal surgeries under spinal anaesthesia with respect to postoperative pain control, duration of analgesia, pain intensity (VAS score ) |