| CTRI Number |
CTRI/2026/01/100657 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing a numbing cream and a patch to reduce pain from spinal needle insertion |
|
Scientific Title of Study
|
A Comparative Study of Eutectic Mixture of Local Anaesthetic Cream ( EMLA) and Lignocaine Patch ( 5%) to Alleviate Pain on Needle Insertion During Spinal Anaesthesia in a Tertiary Care Centre |
| 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. Narendra Babu M. C. |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre,Bangalore |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,
15/1 Hesaraghatta Main Road, Chikkasandra, Bengaluru, Karnataka
Bangalore KARNATAKA 560090 India |
| Phone |
99002140664 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Narendra Babu M. C. |
| Designation |
Postgraduate |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre, Bangalore |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,
15/1 Hesaraghatta Main Road, Chikkasandra, Bengaluru, Karnataka
Bangalore KARNATAKA 560090 India |
| Phone |
8095353750 |
| Fax |
|
| Email |
narendrababuchanappa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Asma Kaleem Pasha |
| Designation |
Postgraduate |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre, Bangalore |
| Address |
Sapthagiri Institute of Medical Sciences and Research Centre,
15/1 Hesaraghatta Main Road, Chikkasandra, Bengaluru, Karnataka
Bangalore KARNATAKA 560090 India |
| Phone |
8095353750 |
| Fax |
|
| Email |
asmakp27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta Main Road, Chikkasandra, Bengaluru – 560090, Karnataka, India.
The study has no external funding and is supported by the institute with infrastructural and logistic facilities. Minor expenses are borne by the student investigator. |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
No. 15, Chikkasandra, Hesaraghatta Main Road, Bangalore – 560090, Karnataka, India |
| 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 Asma Kaleem Pasha |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of Anaesthesiology, 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 Bangalore KARNATAKA |
08095353750
asmakp27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Sapthagiri Institute of Medical Sciences and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EMLA Cream (Eutectic Mixture of Local Anaesthetic Cream) |
A topical anesthetic cream containing 2.5% lidocaine and 2.5% prilocaine, applied 1 hour before spinal needle insertion. |
| Comparator Agent |
Lignocaine Patch (5%) |
A topical lignocaine patch containing 5% lignocaine, applied 1 hour before spinal needle insertion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient posted for infra umbilical surgical procedure under spinal anesthesia.
2 Age 18-60 years.
3 ASA grade I & II.
4 Weight of the patient 45-70 kgs.
5 Patient who consent for the procedure |
|
| ExclusionCriteria |
| Details |
1 Patient not willing to participate in the study.
2 Contraindication for spinal anesthesia.
3 Hypersensitivity /Allergy to study drug.
4 Pregnant women or lactating women
5 More than three attempts of spinal needle insertion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain score on spinal needle insertion using Visual Analogue Scale (VAS) |
Immediately after spinal needle insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| measuring patient satisfaction, hemodynamic response, adverse effects |
At the time of needle insertion, 5minutes, 10 minutes & 15 minutes after insertion |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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="0" Months="3" 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
|
Spinal anesthesia is commonly used for surgeries of the lower limbs, pelvis and abdomen. The insertion of the spinal needle can cause discomfort and anxiety in many patients despite the overall good tolerance of the procedure. To reduce the pain of needle puncture, topical local anesthetics can be applied to the skin before spinal anesthesia.
Eutectic Mixture of Local Anaesthetic cream containing 2.5 percent lignocaine and 2.5 percent prilocaine is widely used for skin anesthesia in pediatric venipuncture and lumbar puncture. Lignocaine patch 5 percent has been shown to reduce pain in conditions such as post herpetic neuralgia and painful diabetic neuropathy and is also effective in providing local analgesia.
This randomized controlled study aims to compare the effectiveness of EMLA cream and 5 percent lignocaine patch in alleviating pain during spinal needle insertion. Ninety adult patients undergoing elective surgery under spinal anesthesia will be randomly allocated into two groups to receive either EMLA cream or lignocaine patch at the puncture site prior to the procedure. Pain during spinal needle insertion will be assessed using the Visual Analogue Scale. The primary outcome is the difference in pain scores between the two groups and secondary outcomes include ease of needle insertion and patient satisfaction. The study will be conducted at Sapthagiri Institute of Medical Sciences and Research Centre Bangalore. |