| CTRI Number |
CTRI/2026/01/101538 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study on efficacy of 5% Lidocaine patch for postoperative pain
management |
|
Scientific Title of Study
|
A study on efficacy of 5 percent Lidocaine Patch for postoperative pain
management in patient undergoing Laparoscopic Cholecystectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwani kumar |
| Designation |
resident doctor |
| Affiliation |
Mahatam Gandhi Medical College |
| Address |
department of anaesthseiology, Mahatma Gandhi Medical College, RIICO Institutional Area Sitapura, Tonk Road, Jaipur, Rajasthan
12,teachers colony, ajmer road, DCM
Jaipur
RAJASTHAN
302022
India |
| Phone |
7838031688 |
| Fax |
|
| Email |
drashwanikumar0509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prachi Verma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College |
| Address |
department of anaesthesiology, RIICO Institutional Area Sitapura, Tonk Road, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829191038 |
| Fax |
|
| Email |
drprachiverma@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Verma |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College |
| Address |
RIICO Institutional Area Sitapura, Tonk Road, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9829191038 |
| Fax |
|
| Email |
drprachiverma@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical college,RIICO Institutional Area Sitapura, Tonk Road, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Ashwani kumar |
| Address |
Mahatma Gandhi Medical College,RIICO Institutional Area Sitapura, Tonk Road, Jaipur, Rajasthan, 302022, India
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| Ashwani kumar |
mahatama gandhi hospital |
Department of Anaesthesiology, RIICO Industrial area, sitapura
Jaipur
RAJASTHAN |
7838031688
drashwanikumar0509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma gandhi medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dressing tape |
dressing tape will be applied on patient undergoing laparoscopic cholecystectomy once pre operatively & the effect will be monitored for 48 hours. |
| Intervention |
local application of 5% Lidocaine patch . |
patient undergoing laparoscopic cholecystectomy will be given patch once pre operatively & the effect of the drug will be monitored for 48 hours.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with American Society of anesthesiologists (ASA) Class I & II.
Patients scheduled for Laparoscopic cholecystectomy surgery. |
|
| ExclusionCriteria |
| Details |
Patient with known psychiatric disorders, coagulopathy disorders, history Cerebrovascular
disease.
Pregnant and Lactating patients.
Inability to understand VAS scoring.
Infection at local needle site insertion. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decreased postoperative pain
Decreased postoperative analgesia use
Early mobilization |
baseline, postoperative day 1, post operative day 3
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/01/2026 |
| 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="12"
Months="0"
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
|
A study on efficacy of Lidocaine patch for postoperative pain
management in patient undergoing Laparoscopic Cholecystectomy. This is a human study, to benefit the patients undergoing laparoscopic
cholecystectomy surgery by decreasing the postoperative pain. A total of 80 patients will be randomly divided into two groups of 40 each with
the help of computer-generated random numbers. Group A will be given lidocain
patch & Group B will receive dressing patch as placebo. there response to pain will be observed for post op day 3. Primary Objectives is To compare the postoperative pain score of two groups using Visual Analogue Scale score at different time period. |