| CTRI Number |
CTRI/2023/05/053222 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
28/05/2023 |
| 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
|
study to see the effect of oral pregabalin if given before laparoscopic cholecystectomy surgery on pain occurring after surgery and the need for additional analgesic |
|
Scientific Title of Study
|
Effect of preoperative administration of oral pregabalin on post-operative pain intensity and analgesic requirement following laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Gupta |
| Designation |
Resident |
| Affiliation |
Mahatma Gandhi Medical College |
| Address |
Department of anesthesia, Mahatma Gandhi Medical College, Jaipur.
Jaipur
RAJASTHAN
302022
India |
| Phone |
9621103819 |
| Fax |
|
| Email |
gupta.swati0922@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh R Nimje |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College |
| Address |
Department of anesthesia, Mahatma Gandhi Medical College, Jaipur.
Jaipur
RAJASTHAN
302022
India |
| Phone |
9503332784 |
| Fax |
|
| Email |
ganesh.nimje8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh R Nimje |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College |
| Address |
Department of Anesthesia,
Mahatma Gandhi Medical College, Jaipur.
Jaipur
RAJASTHAN
302022
India |
| Phone |
9503332784 |
| Fax |
|
| Email |
ganesh.nimje8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Mahatma Gandhi Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College Hospital Jaipur |
| Address |
Mahatma Gandhi Medical College Hospital, Ricco industrial area, sitapura, jaipur, rajasthan |
| 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 |
| Swati gupta |
Mahatma Gandhi Medical College |
OT COMPLEX, Surgery division
Department of Anesthesiology
Jaipur
RAJASTHAN |
9621103819
gupta.swati0922@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo |
dose: 150 mg
frequency: once before surgery
route: oral |
| Intervention |
Pregabalin |
dose: 150 mg
frequency: once before surgery
route: oral
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologists (ASA) I and II patients.
2.Age group of 18-65 years.
3.Patient with written valid consent.
4.Patient undergoing elective laparoscopic cholecystectomy.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal to participate in study.
2.History of allergy to study drug.
3.Pregnant and Lactating women.
4.Patient with impaired liver or kidney function.
5.History of chronic pain or daily intake of analgesics.
• History of chronic use of central nervous system depressant drugs and anti-convulsant.
• Morbidly obese.
• Inability to comprehend or participate in pain scoring system. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the post operative pain intensity at rest and on movement.
To assess total dose of rescue analgesia required in first 24 hours |
0 hour
8 hour
16 hour
24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess severity and side effects of drug |
post operatively |
|
|
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)
|
24/07/2023 |
| 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 Yet Recruiting |
| 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
|
Laproscopic cholecystectomy is one of common surgical procedure, however post operative pain associated with it remains a major challenge. Post operative pain has been treated with many classes of drug available, but they have wide range of side effects. This study is aimed to evaluate the effectiveness of oral pregabalin on post operative pain intensity and analgesic requirement. |