| CTRI Number |
CTRI/2023/11/059804 [Registered on: 14/11/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare and evaluate efficacy of preoperative dose of oral Pregabalin versus oral Gabapentine
on the duration of postoperative analgesia in patients undergoing elective Modified Radical Mastectomy under general anaesthesia |
|
Scientific Title of Study
|
A prospective randomised comparative study of the effect of preemptive dose of oral Pregabalin
versus oral Gabapentine on postoperative analgesia and total analgesic consumption in Radical Mastectomy under general anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi S G |
| Designation |
PG student, Anesthesiology |
| Affiliation |
Mysore medical College and research institute |
| Address |
Department of Anesthesiology, Mysore medical College and research institute,Irwin road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
8884880752 |
| Fax |
|
| Email |
vaishu.rajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh G |
| Designation |
Professor, Department of Anesthesiology |
| Affiliation |
Mysore medical College and research institute |
| Address |
Department of Anesthesiology, Mysore medical College and research institute,Irwin road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
7676775491 |
| Fax |
|
| Email |
dineshgovindarao@gmail.Com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi S G |
| Designation |
PG student, Anesthesiology |
| Affiliation |
Mysore medical College and research institute |
| Address |
Department of Anesthesiology, Mysore medical College and research institute,Irwin road, Mysore
Mysore
KARNATAKA
570001
India |
| Phone |
8884880752 |
| Fax |
|
| Email |
vaishu.rajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore medical College and research institute,Irwin road, Mysore |
|
|
Primary Sponsor
|
| Name |
Mysore medical College and research institute |
| Address |
Irwin road , next to railway station, mysore, Karnataka, 570001 |
| Type of Sponsor |
Government 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 Vaishnavi S G |
Krishnarajendra Hospital, Mysore Medical college and research institute |
Department of Anesthesiology, Room no.1, 1st floor, New stone building, KR Hospital,Mysore medical College and research institute, Irwin road ,Mysore
Mysore
KARNATAKA |
8884880752
vaishu.rajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mysore medical College and research institute and associated hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Preemptive dose of oral
Pregabalin |
Administering the study drug-single dosage of tablet
Pregabalin 150 mg orally
with a sips of water to the
participants 2 hour before the
surgery . |
| Comparator Agent |
Preemptive dose of oral Gabapentine |
Administering the study drug-single dosage of tablet
Gabapentine 600mg orally with
sips of water 2 hours before the
surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All ASA grade I and II patients between 18 to 60 years age group with carcinoma breast posted for elective Modified Radical Mastectomy surgeries will be recruited for the study after obtaining written informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with Cardiovascular, Respiratory, Renal and Neurological disorders
Patients with coagulation abnormalities
Patients with chronic pain conditions and taking analgesics
Obesity (BMI>30kg/m2)
Patients with history of psychiatric disorders or on anti-psychotic drugs
Patients on oral anticoagulants, anti-epileptic drugs, opioids
Patients with history of alcohol abuse
Any known drug allergy to the study drugs |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the efficacy of single
preemptive dose of oral Pregabalin versus oral
Gabapentine on the duration of postoperative
analgesia and total analgesic consumption in
patients undergoing elective Modified Radical Mastectomy under general anaesthesia |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To record the intraoperative hemodynamic
changes at specified intervals with Pregabalin and
Gabapentine premedication |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/11/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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
|
It is a Comparative study to evaluate efficacy of preemptive dose of oral Pregabalin versus oral Gabapentine on the duration of postoperative analgesia in patients undergoing elective Modified Radical Mastectomy under general anaesthesia |