| CTRI Number |
CTRI/2021/11/038199 [Registered on: 23/11/2021] Trial Registered Prospectively |
| Last Modified On: |
18/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To assess whether pregabalin and amitriptyline can modify postoperative pain when given before surgery |
|
Scientific Title of Study
|
Comparative study of oral pregabalin versus oral amitriptyline as preemptive analgesic agent in patients undergoing inguinal hernioplasty surgeries under spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anitha |
| Designation |
Postgraduate resident |
| Affiliation |
Bundelkhand medical college |
| Address |
Department of Anaesthesiology,
Bundelkhand medical college.
Sagar
MADHYA PRADESH
470001
India |
| Phone |
8248085774 |
| Fax |
|
| Email |
anitha.veronica15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Jain |
| Designation |
Professor and HOD |
| Affiliation |
Bundelkhand medical college |
| Address |
Department of Anaesthesiology,
Bundelkhand medical college.
Sagar
MADHYA PRADESH
470001
India |
| Phone |
9424422744 |
| Fax |
|
| Email |
freegasflow@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anitha |
| Designation |
Postgraduate resident |
| Affiliation |
Bundelkhand medical college |
| Address |
Department of Anaesthesiology,
Bundelkhand medical college.
Sagar
MADHYA PRADESH
470001
India |
| Phone |
8248085774 |
| Fax |
|
| Email |
anitha.veronica15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patients undergoing inguinal hernioplasty surgeries under spinal anaesthesia at Bundelkhand medical college, Sagar. |
|
|
Primary Sponsor
|
| Name |
Dr Anitha |
| Address |
Department of Anaesthesiology,
Bundelkhand medical college,
Sagar. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvesh Jain |
Professor and HOD,
Department of Anaesthesiology,
Bundelkhand medical college,
Sagar. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anitha |
Bundelkhand medical college |
Department of Anesthesiology,
Bundelkhand medical college,
Sagar,
Madhya Pradesh.
Sagar
MADHYA PRADESH |
8248085774
anitha.veronica15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical 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 |
C.Pregabalin |
75mg single dose 2 hours before surgery |
| Intervention |
T.Amitriptyline |
10mg single dose 2 hours before surgery |
| Comparator Agent |
T.Ranitidine(placebo) |
150 mg single dose 2 hours before surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiologists physical status 1 and 2
2.Patients posted for elective inguinal hernioplasty surgery |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Known sensitivity to Pregabalin and Amitriptyline
3.History of seizure disorder
4.Known psychiatric disorder
5.History of chronic pain and chronic daily intake of analgesic
6.Liver or renal disease
7.History of drug or alcohol abuse
8.Pregnancy and breastfeeding mothers |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of pregabalin and amitriptyline in the prevention of postoperative pain |
24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure intensity of acute postoperative pain |
24 hours post surgery |
| Use of rescue analgesics |
24 hours post surgery |
| Side effects of pregabalin and amitriptyline |
24 hours post 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)
|
25/11/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
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, randomised, double blinded, placebo controlled study to evaluate the postoperative analgesic benefit in patients administered with pregabalin or amitriptyline as premedication for patients undergoing inguinal hernioplasty surgeries under spinal anaesthesia and to compare their postoperative efficacy with respect to increase in duration of analgesia, reduction in total postoperative requirement of analgesics and study the adverse effects, if attributable to both drugs |