| CTRI Number |
CTRI/2026/01/101669 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparative study of efficacy of 5% lignocaine patch for post-operative pain control in heart surgery patients |
|
Scientific Title of Study
|
Comparative study of efficacy of 5% lignocaine patch for post-operative analgesia in cardiac surgical patients: A cross-sectional controlled trial |
| 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 Jaslin Biswajit Acharya |
| Designation |
Junior Resident |
| Affiliation |
MGM Medical College and Hospital |
| Address |
Department of Anaesthesiology, 5rd floor, MGM Medical College and Hospital, N6 CIDCO Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
7218245980 |
| Fax |
|
| Email |
jaslinacharya8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajita Annachhatre |
| Designation |
Associate Professor |
| Affiliation |
MGM Medical College and Hospital |
| Address |
Department of Anaesthesiology, 5rd floor, MGM Medical College and Hospital, N6 CIDCO Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9011672130 |
| Fax |
|
| Email |
sannachhatre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajita Annachhatre |
| Designation |
Associate Professor |
| Affiliation |
MGM Medical College and Hospital |
| Address |
Department of Anaesthesiology, 5rd floor, MGM Medical College and Hospital, N6 CIDCO Chhatrapati Sambhajinagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9011672130 |
| Fax |
|
| Email |
sannachhatre@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital, Chhatrapati Sambhajinagar |
|
|
Primary Sponsor
|
| Name |
MGM Medical College and Hospital |
| Address |
MGM Medical College and Hospital N6 CIDCO Chhatrapati Sambhajinagar 431003 |
| 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 Ajita Annachhatre |
Mahatma Gandhi Mission Hospital |
Department of Anaesthesiology, 5th floor, N6 Cidco, Chhatrapati Sambhajinagar 431003
Aurangabad
MAHARASHTRA |
9011672130
sannachhatre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects |
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 |
5% lignocaine patch |
Transdermal patch of 5% lignocaine applied once post operatively near the incision site to assess duration of post operative analgesia and kept till patient complaints of pain |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients giving consent for procedures
2) Patients in the age group of 20-75 years
3) Patients scheduled to undergo cardiac surgery through a full median sternotomy approach. |
|
| ExclusionCriteria |
| Details |
1) Known hypersensitivity or allergic reaction to lignocaine patches.
2) Current use of Class I antiarrhythmic medications, such as
lignocaine, tocainide, procainamide, mexiletine, or
propafenone.
3) Preoperative use of medications for acute or chronic pain
conditions, including non-steroidal anti-inflammatory drugs
(NSAIDs), tramadol, opioids, antidepressants, or
anticonvulsants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Use of 5% lignocaine patch resulted in improved post operative analgesia in cardiac surgery patients compared to patients who did not receive the patch |
Post operative analgesia calculated according to VAS score at time points of 3hrs, 6hrs, 12hrs and 24 hrs after application of patch |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The duration of analgesia
The time for extubation
The total length of ICU stay
The incidence of opioid related adverse effects such as nausea, vomiting,
pruritis. |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/02/2026 |
| 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="2"
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
|
Post-sternotomy pain remains a significant clinical challenge in cardiac
surgery, often requiring substantial analgesic requirement in the immediate
postoperative period. While opioids are effective analgesics, their adverse
effect profile; including respiratory depression, sedation, gastrointestinal
dysfunction, and risk of long-term dependence; underscores the urgent need
for opioid-sparing strategies. Topical lidocaine in the form of a 5% transdermal patch offers a non-invasive, low-
risk intervention that provides localized analgesia with minimal systemic
absorption. Although lidocaine patches have demonstrated efficacy in treating
neuropathic and localized pain conditions, their role in the management of acute
post-sternotomy pain remains underexplored. This study proposes to evaluate the efficacy of the 5% lidocaine patch in reducing
post-sternotomy pain and opioid requirements within the first 24 hours following
cardiac surgery. By addressing a key gap in postoperative pain management, this
research has the potential to inform enhanced recovery pathways, reduce opioid
exposure, and improve patient outcomes in a high-risk population |