| CTRI Number |
CTRI/2026/02/104578 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Biological Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Usefulness of a pad soaked with pain relieving medicine for Reducing Pain and Ensuring Effectiveness of Injections to prevent Rabies following animal exposures |
|
Scientific Title of Study
|
Effect of 2% Lignocaine Medicated Pad (LMP) Administration on Pain Relief and Antibody Response During Rabies Immunoglobulin (RIG) Infiltration: A multicentric randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zinia Thajudeen Nujum |
| Designation |
Additional Professor |
| Affiliation |
School of Public Health, Kerala University of Health Sciences |
| Address |
School of Public Health , Kerala University of Health Sciences Government Medical College, Thiruvananthapuram Campus Thiruvananthapuram KERALA 695011 India |
| Phone |
09037356908 |
| Fax |
|
| Email |
drzinia@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Zinia Thajudeen Nujum |
| Designation |
Additional Professor |
| Affiliation |
School of Public Health, Kerala University of Health Sciences |
| Address |
School of Public Health , Kerala University of Health Sciences Government Medical College, Thiruvananthapuram Campus Thiruvananthapuram KERALA 695011 India |
| Phone |
09037356908 |
| Fax |
|
| Email |
drzinia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Zinia Thajudeen Nujum |
| Designation |
Additional Professor |
| Affiliation |
School of Public Health, Kerala University of Health Sciences |
| Address |
School of Public Health , Kerala University of Health Sciences Government Medical College, Thiruvananthapuram Campus Thiruvananthapuram KERALA 695011 India |
| Phone |
09037356908 |
| Fax |
|
| Email |
drzinia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research Investigator initiated Small Grant
Indian Council of Medical Research (ICMR)
V. Ramalingaswami Bhawan,
P.O. Box No. 4911,
Ansari Nagar,
New Delhi – 110029,
India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Indian Council of Medical Research (ICMR) V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi – 110029, India
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Muraleedhar Thambe |
BJ Medical College, Pune |
BJ Medical College, Pune Pune MAHARASHTRA |
9423007898
muralidhartambe@gmail.com |
| Chintha Sujatha |
Government Medical College, Kollam |
Government Medical College, Kollam Kollam KERALA |
9447375532
sujathachintha@gmail.com |
| Asuma A Rahim |
Government Medical College, Kozhikode |
Preventive Clinic
Government Medical College, Kozhikode Kozhikode KERALA |
9846120001
rahmaniyas@gmail.com |
| Anitha Bhaskar |
Government Medical College, Thiruvananthapuram |
Preventive Clinic
Government Medical College
Thiruvananthapuram Thiruvananthapuram KERALA |
9447039135
dranithabhaskar@gmail.com |
| Jugal Kishore |
Vardhman Mahavir Medical College & Safdarjung Hospital, Delhi (VMMC & SJH) |
Emergency Medicine, Vardhman Mahavir Medical College & Safdarjung Hospital, Delhi (VMMC & SJH) New Delhi DELHI |
9582792331
jk@drjugalkishore.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Human ethics Committee, Government Medical College Kollam |
Approved |
| Human ethics Committee, Medical College Thiruvananthapuram |
Approved |
| Institutional Ethics Committee Government Medical College Kozhikode |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W540||Bitten by dog, (2) ICD-10 Condition: W558||Contact with other mammals, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% Lignocaine Medicated Pad |
Dose 2% Lignocaine 5ml or the volume required to soak the pad and cover the wound
frequency - single application
twenty minutes before rabies immunoglobulin administration
Route - local application
Total duration - 20 minutes
The procedure shall be done after administering the test dose of ERIG, so as to allow at least 20 minutes of contact with the local anaesthetic. Patient will be requested to lie in bed, in supine or prone position, depending on the site of wound. Sterile cotton pad shall be placed over the wound site. A number of such pads will be placed so as to cover the wound site. Lignocaine shall be instilled over the pads till the wet appearance is seen over the entire pads placed. The maximum volume of lignocaine will be 5ml, taken in a 5ml syringe. The pad will be securely plastered/ bandaged according to the site |
| Comparator Agent |
Normal Saline |
Normal saline will be used as placebo. It will be taken in same type of syringe and the same volume as the intervention. The intervention and placebo shall be administered by the same person. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Adult Patients more than 18 years coming to the Preventive Clinic or Antirabies clinic with Category three animal bites in whom Rabies Immunoglobulin Equine Rabies immunoglobulin or Human Rabies Immunoglobulin is advised.
Children between 12 and 18 years with Category three animal bites in whom Rabies Immunoglobulin Equine Rabies immunoglobulin Human Rabies Immunoglobulin is advised will also be recruited after completion of six months of data collection and after the first DSMB review
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria are those who are not giving consent, known allergy to Lignocaine, history of contact dermatitis, any contraindications to lignocaine and all mucosal exposures. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in Pain score in the intervention and control arm measured by Visual Analog Scale and Sound Eye Motor Scale |
Before Rabies Immunoglobulin (RIG) administration
During RIG Administration
After RIG administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cost-effectiveness |
one point after the procedure |
| adverse events |
till 42 days |
| factors determining immune response |
one point during analysis |
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
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)
|
01/04/2026 |
| 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="3" Months="0" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 10-04-2029 and end date provided 10-04-2034?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rationale The administration of Rabies Immunoglobulin RIG is a painful procedure. Local application of painrelieving medications has been used for many other procedures effectively. Assessing antibody titres helps to see whether a lignocaine medicated pad interferes with immune response. It also provides an opportunity to determine effective immune response and factors affecting it. Novelty No previous studies other than a small clinical trial by our team. Objectives To find the effect 2 percent Lignocaine Medicated Pad LMP on pain relief and antibody response during Rabies Immunoglobulin administration factors determining antibody response, frequency of adverse events following RIG administration and cost effectiveness of procedure. Methods A randomized triple blind controlled trial will be done in three sites in India in tertiary care settings. Patients with Category III animal bite wounds will be randomized to intervention and placebo arms based on a previously generated random number sequence. Sterile gauze pads soaked with 2% lignocaine and normal saline will be intervention and placebo, respectively. Pain relief and antibody response will be the primary outcomes measured. Pain relief will be assessed using a numeric rating scale NRS and sound, eye and motor pain SEM scale. Costeffectiveness will be assessed by calculating the incremental cost-effectiveness ratio ICER determining the willingness to pay WTP threshold by the contingent valuation method. If the ICER falls below this WTP threshold the intervention will be considered cost-effective. Expected Outcome A cost-effective procedure for pain relief during RIG administration, which can be included in the national policy and guidelines for rabies management. |