| CTRI Number |
CTRI/2026/02/104512 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Of Lignocaine Skin Patch On Postoperatively Pain Relief After Kidney Stone Surgery PCNL |
|
Scientific Title of Study
|
Evaluation Of The Efficacy Of Transdermal 5 Percent Lignocaine Patch For Postoperative Pain Relief Following Percutaneous Nephrolithotomy A Prospective Study |
| 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 Sandip Baheti |
| Designation |
Professor Department Of Anaesthesiology |
| Affiliation |
Dr Dy Patil Medical College Hospital And Research Centre Pimpri Pune |
| Address |
Dr Dy Patil Medical College Hospital And Research Centre Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822014401 |
| Fax |
|
| Email |
snbacademics12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishna Patil |
| Designation |
Anaesthesia Resident |
| Affiliation |
Dr Dy Patil Medical College Hospital And Research Centre Pimpri Pune 411018 |
| Address |
Dr Dy Patil Medical College Hospital And Research Centre Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7863864542 |
| Fax |
|
| Email |
krishpatil5451@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishna Patil |
| Designation |
Anaesthesia Resident |
| Affiliation |
Dr Dy Patil Medical College Hospital And Research Centre Pimpri Pune 411018 |
| Address |
Dr Dy Patil Medical College Hospital And Research Centre Pimpri Pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7863864542 |
| Fax |
|
| Email |
krishpatil5451@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self Funded Dr D Y Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr DY Patil Medical College Hospital and Research Centre Pimpri Pune |
| Address |
Dr DY Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018 |
| 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 Krishna Patil |
Dr DY Patil Medical College, Hospital and Research Centre |
Dr DY Patil Medical College, Hospital and Research Centre
sant tukaram nagar, pimpri,pune
Department of Anaesthesiology
Pune
MAHARASHTRA |
7863864542
krishpatil5451@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
lignocaine 5 percent transdermal patch |
Transdermal lignocaine 5 percent patch applied at surgical site following completion of percutaneous nephrolithotomy
patch applied immediately after surgery and kept for twelve hours patients monitered for postoperative pain using visual analogue scale and rescue analgesia with intravenous paracetamol administered when required
Transdermal 5 percent lignocaine patch applied over the surgical incision site at the end of surgery
One patch 5 percent 10 length 14 width applied for 12 hours Postoperatively
Route Transdermal |
| Comparator Agent |
Placebo Patch |
Placebo patch applied at surgical site following completion of percutaneous nephrolithotomy similar in apperance to active patch
postoperative pain assessed using visual analogue scale and rescue analgesia administered as per study protocol
Standard Postoperative analgesia as per Protocol Intravenous Paracetamol 1 Gram every 6 hours for 12 hours Postoperatively
Route Intravenous
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients Aged 18 to 65 Years Undergoing Elective Percutaneous Nephrolithotomy Under General Anaesthesia or Regional Anaesthesia
American Society of Anaesthesiology Physical Status 1 and 2
Patients willing and Able to Provide Written Informed Consent |
|
| ExclusionCriteria |
| Details |
Know Allergy or Hypersensitivity to Lignocaine or Amide Local Anesthetics
Patients with Psychiatric illness or communication difficultly
Patient with chronic pain disorders or on chronic analgesic therapy
Skin lesion infection or dermatitis at patch application site
Pregnant and lactating women
Patient with significant hepatic renal or cardiac dysfunction
Refusal to participate in study
Patient requiring epidural anaesthesia or combined spinal epidural technique |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post Operative Pain Intensity Measured Using Visual Analog Scale |
Two Four Six Twelve Hours Postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total Rescue Analgesia Consumption in 12 hours
Time Of First Rescue Analgesia after surgery within 12 hours
Incidence Of Adverse Effects Like Skin Reaction Nausea Vomiting within 12 hours Postoperatively
Patient Satisfaction Score at 12 hours Postoperatively |
2 hours
4 hours
6 hours
12 hours |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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 3 |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="1"
Months="6"
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
|
This prospective randomized double blind placebo controlled study aims to evaluate the efficacy of transdermal five percent lignocaine patch in reducing postoperative pain following percutaneous nephrolithotomy. Adult patients undergoing elective percutaneous nephrolithotomy will be randomly allocated into lignocaine patch group and placebo patch group. The study patch will be applied at the surgical site after completion of surgery. Postoperative pain will be assessed using visual analog scale at predefined time intervals up to twelve hours. Rescue analgesia with intravenous paracetamol will be administered when required. Total analgesic consumption time to first rescue analgesia and adverse effects will be recorded. The study aims to determine whether transdermal lignocaine patch provides effective postoperative analgesia and reduces analgesic requirement in patients undergoing percutaneous nephrolithotomy. |