FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/096220 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 18/10/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Using a 5 percent Lignocaine Patch to Reduce Pain and Improve Satisfaction in Patients Receiving Spinal Anesthesia 
Scientific Title of Study   Role of 5 percent Lignocaine Patch in Reducing Pain and Improving Patient Satisfaction During SpinalAnesthesia – An Observational 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. Akshaya N. Shetti 
Designation  Professor and HOD , Department of Anesthesiology  
Affiliation  Pravara Institute Of Medical Sciences, Loni 
Address  Rural Medical College, Pravara Institute of Medical Sciences, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7385566253  
Fax    
Email  aksnsdr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Akshaya N. Shetti 
Designation  Professor and HOD , Department of Anesthesiology  
Affiliation  Pravara Institute Of Medical Sciences, Loni, Ahmednagar, 413736 
Address  Rural Medical College, Pravara Institute of Medical Sciences, Loni, Ahmednagar, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7385566253  
Fax    
Email  aksnsdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Akshaya N. Shetti 
Designation  Professor and HOD , Department of Anesthesiology  
Affiliation  Pravara Institute Of Medical Sciences, Loni 
Address  Rural Medical College, Pravara Institute of Medical Sciences, Loni

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7385566253  
Fax    
Email  aksnsdr@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology and Critical Care, Pravara Institute Of Medical Sciences, Loni, Ahmednagar, 413736. 
 
Primary Sponsor  
Name  Dr Akshaya N Shetti 
Address  Pravara Institute Of Medical Sciences, Loni , Ahmednagar, Maharashtra, India , 413736. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshaya N Shetti  Pravara Institute Of Medical Sciences  Department of Anesthesiology, critical care unit, Rural Medical College, Pravara Institute Of Medical Sciences, Loni, 413736
Ahmadnagar
MAHARASHTRA 		 7507807673

aksnsdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee , Pravara Institute Of Medical Sciences- Deemed University (IEC UG/PG RMC )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults more than 18 years undergoing elective surgery under spinal anaesthesia.
ASA physical status I–III.
Provided written informed consent. 
 
ExclusionCriteria 
Details  Known allergy to lignocaine or amide local anaesthetics.
Skin lesions or infections at patch site.
Contraindications to spinal anaesthesia. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain score at the site of spinal needle insertion measured using Visual Analogue Scale (VAS) immediately after spinal anesthesia.
 		 Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of local skin irritation or allergy at the site of patch application.

Ease of spinal anesthesia performance as rated by the anesthesiologist (subjective 3 or 5 point scale). 		 Baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   07/11/2025 
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="1"
Days="7" 
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   Spinal anesthesia is one of the most commonly performed regional anesthetic techniques worldwide, especially for lower abdominal, pelvic, and lower limb surgeries. It offers numerous advantages, including rapid onset of anesthesia, profound sensory and motor block, avoidance of airway instrumentation, reduced blood loss, and early postoperative recovery. Despite these benefits, patients often experience discomfort or pain during the procedure, particularly at the time of spinal needle insertion. This moment of pain can heighten anxiety, reduce cooperation, and negatively affect the overall patient experience with anaesthesia. In the context of spinal anaesthesia, pre-application of a 5% lignocaine patch over the proposed lumbar puncture site offers several potential advantages: Non-invasive dermal anaesthesia without additional injections, Reduced pain perception during spinal needle insertion, Increased patient comfort and satisfaction, which may enhance overall perioperative experience, Ease of application and time efficiency for anaesthesiology staff. This study has therefore been designed as a prospective observational study to document the pain experienced during spinal needle insertion and the overall satisfaction of patients after pre-procedure application of a 5% lignocaine patch. The findings will help clarify whether this simple intervention can improve patient comfort and inform larger comparative or randomized studies in the future.  The study population will consist of adult patients scheduled to undergo elective surgical procedures under spinal anesthesia at the Department of Anesthesiology and Critical Care, Dr Balasaheb Vikhe Patil Rural Medical College. All participants will receive a 5% lignocaine patch at the proposed lumbar puncture site before the spinal anesthesia procedure. Eligible patients will be screened and consented one day before surgery.
On the day of surgery, demographic details and relevant medical history will be recorded on a pre-designed case record form (CRF).

Data Collection 
1. Recruitment and ConsentAll adult patients scheduled for elective lower abdominal or lower limb surgery under spinal anaesthesia in the Department of Anaesthesiology will be screened for eligibility. After verifying inclusion and exclusion criteria, eligible patients will be approached one day prior to surgery. Written informed consent will be obtained in their preferred language after explaining the nature and purpose of the study, potential risks, and benefits.
2. Application of 5% Lignocaine PatchA 5% lignocaine patch will be applied at the intended lumbar puncture site approximately 60 minutes prior to the procedure, as per manufacturer’s instructions. Time of application and removal will be documented.
3. Spinal Anaesthesia Procedure DataDuring spinal anaesthesia, the following procedural details will be recorded:• Level of spinal needle insertion (L3–L4 or L4–L5)• Needle size and type used• Number of attempts at lumbar puncture• Duration between patch removal and spinal needle insertion• Any adverse reactions (local skin reactions, systemic effects)
4. Pain MeasurementImmediately after spinal needle insertion, the patient will be asked to rate the pain using a 10-cm Visual Analogue Scale (VAS) where 0 represents no pain and 10 represents the worst possible pain. This VAS score will be recorded in the CRF.
5. Patient SatisfactionWithin 30–60 minutes postoperatively, patients will be asked to rate their satisfaction with the procedure using a 5-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied). This will also be recorded.
6. Safety MonitoringAny adverse events, allergic reactions, or unexpected side effects during or after the patch application and spinal anaesthesia will be documented. Appropriate medical management will be provided if necessary.
7. Data Entry and StorageAll collected data will be entered into a secure, password-protected electronic database by trained research personnel. Paper CRFs will be stored in locked cabinets accessible only to the investigators. Data confidentiality will be maintained throughout the study.
8. Data Quality AssuranceRegular cross-checking of entries between CRFs and the electronic database will be conducted to ensure accuracy and completeness. Any missing or inconsistent data will be verified with the source documents.

Aims and Objectives 
1. To assess pain experienced by patients during spinal needle insertion after application of 5% lignocaine patch.
2. To evaluate patient satisfaction with the procedure.

Material and Methods
Study Type:Observational 
Study Design: Cross-sectional 
Setting: Department of Anesthesiology and Critical Care ,Dr Balasaheb Vikhe Patil Rural Medical College

Methodology
1. A 5% lignocaine patch will be applied at the intended lumbar puncture site approximately 60 minutes before the spinal procedure according to the manufacturer’s guidelines. 2.During spinal anaesthesia, the level of needle insertion, needle type, and number of attempts will be recorded. Immediately after needle insertion, pain will be assessed using a     10-cm Visual Analogue Scale (VAS).
3.Within 30–60 minutes post-procedure, patient satisfaction will be assessed using a 5-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied).
4. Any adverse events related to the patch or the procedure will be documented.
5. Data will be collected using standardized CRFs. Baseline demographics, intraoperative parameters, VAS pain scores, satisfaction scores, and any adverse events will be entered into a secure password-protected electronic database. Confidentiality will be maintained.
6.Primary outcome: VAS pain score during spinal needle insertion after application of 5% lignocaine patch.
7. Secondary outcome: Patient satisfaction score after the procedure.
8. Safety outcome: Incidence of local or systemic adverse effects from the patch.

 
Close