| CTRI Number |
CTRI/2026/03/106915 [Registered on: 25/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of Lox 5% lidocaine patch compared with intravenous paracetamol in elective caesarean section patients. |
|
Scientific Title of Study
|
A PROSPECTIVE COMPARATIVE RANDOMIZED CONTROL STUDY OF POST OPERATIVE PAIN MANAGEMENT IN ELECTIVE CESAREAN SECTION USING 5% LIGNOCAINE PATCH VS PARACETAMOL INFUSION |
| 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 Joseph Nixon Mavely |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Medical College |
| Address |
Dept. of Anaesthesia
SMHRC, DMMC,
Wanadongri, Maharashtra
Nagpur
MAHARASHTRA
441110
India |
| Phone |
8848993562 |
| Fax |
|
| Email |
joton.nixon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan Ashokkumar Badwaik |
| Designation |
Professor |
| Affiliation |
Datta Meghe Medical College |
| Address |
Dept. of Anaesthesia
SMHRC, DMMC,
Wanadongri, Maharashtra
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9689892039 |
| Fax |
|
| Email |
painkiller_gab@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjan Ashokkumar Badwaik |
| Designation |
Professor |
| Affiliation |
Datta Meghe Medical College |
| Address |
Dept. of Anaesthesia
SMHRC, DMMC,
Wanadongri, Maharashtra
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9689892039 |
| Fax |
|
| Email |
painkiller_gab@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Joseph Nixon Mavely |
| Address |
Dept. of Anaesthesia
SMHRC, DMMC,
Wanadongri, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
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 JOSEPH NIXON MAVELY |
SHALINITAI MEGHE HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF ANAESTHESIA, DMMC,NAGPUR, MAHARASHTRA
Nagpur
MAHARASHTRA |
8848993562
joton.nixon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,DMMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5% Lignocaine Patch |
Patients in this group will have a 5% Lidocaine transdermal patch applied 1cm above the surgical incision site immediately after surgery. The patch will be left in place for 24 hours postoperatively and removed after that duration |
| Comparator Agent |
Paracetamol Infusion |
Patients in this group will receive Intravenous Paracetamol 1 gram administered slowly over 15 minutes, given every 8 hours postoperatively for a total duration of 24 hours (i.e., 3 doses). First dose will be given immediately after the skin closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients between 18 to 40 years of age, belonging to ASA Physical Status I & II, undergoing elective lower segment caesarean section (LSCS) with singleton pregnancies under spinal anaesthesia will be considered eligible |
|
| ExclusionCriteria |
| Details |
1. Not willing for the consent
2. History of any previous intraabdominal surgery
3. Known allergy or hypersensitivity to Lignocaine, Paracetamol, or any components of the study drugs.
4. Presence of chronic pain disorders or history of long-term analgesic use.
5. Patients with hepatic or renal dysfunction.
6. Presence of coagulopathy, local skin infection at the patch site, or other contraindications to regional anaesthesia.
7. Patients with intraoperative complications (e.g., conversion to general anaesthesia, excessive bleeding) affecting postoperative pain interpretation.
8. Patients unable to understand or comply with pain scoring systems (e.g., due to language barriers, cognitive impairment, or psychiatric illness).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the postoperative analgesic efficacy of a transdermal Lignocaine 5% patch versus intravenous Paracetamol infusion in the immediate postoperative period |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Higher Maternal Satisfaction, Reduced need for rescue analgesia |
First 24 Hours |
|
|
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)
|
04/04/2026 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is a prospective double blind interventional trial comparing a transdermal 5 percent lignocaine patch with intravenous paracetamol infusion for postoperative pain relief in women undergoing elective lower segment cesarean section under spinal anesthesia. Eighty ASA physical status one and two parturients aged 18 to 40 years will be randomized into two equal groups; the lignocaine patch group will receive a 5 percent lidocaine patch applied one centimeter above the incision for 24 hours, and the paracetamol group will receive one gram intravenous paracetamol every eight hours for 24 hours, with diclofenac as rescue analgesia. Pain intensity will be assessed using the Visual Analog Scale at regular intervals up to 24 hours, maternal satisfaction and adverse effects will be recorded, and the main objective is to compare analgesic efficacy, rescue analgesic requirement, and safety between the two regimens using standard statistical tests. |