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CTRI Number  CTRI/2021/04/032982 [Registered on: 20/04/2021] Trial Registered Prospectively
Last Modified On: 09/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparing the efficacy of 3 medicated plasters for reducing of pain during placement of a needle into the veins in patients undergoing surgery 
Scientific Title of Study   Comparison of 5% Lidocaine Transdermal Patch, Transdermal Ketoprofen Patch and Eutectic Mixture of Local Anaesthetic Cream for Pain Relief During Peripheral Venous Cannulation: A Prospective Randomised Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Ramesh Pola 
Designation  Anaesthesia PG Resident 
Affiliation  M S Ramaiah Medical College 
Address  Postgraduate Department of Anaesthesiology, M S Ramaiah Medical College,New BEL Road,MSR Nagar,Mathikere, Bangalore.

Bangalore
KARNATAKA
560054
India 
Phone  8495000133  
Fax    
Email  rahulsaysthat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rahul Ramesh Pola 
Designation  Anaesthesia PG Resident 
Affiliation  M S Ramaiah Medical College 
Address  Postgraduate Department of Anaesthesiology, M S Ramaiah Medical College,New BEL Road,MSR Nagar,Mathikere, Bangalore.

Bangalore
KARNATAKA
560054
India 
Phone  8495000133  
Fax    
Email  rahulsaysthat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sadasivan S Iyer 
Designation  Assistant Professor, Department of Anaesthesiology  
Affiliation  M S Ramaiah Medical College  
Address  Department of Anaesthesiology, M S Ramaiah Medical College,New BEL Road,MSR Nagar,Mathikere, Bangalore.

Bangalore
KARNATAKA
560054
India 
Phone  8971026127  
Fax    
Email  sadashivaniyer@gmail.com  
 
Source of Monetary or Material Support  
M S RAMAIAH MEDICAL COLLEGE AND HOSPITALS  
 
Primary Sponsor  
Name  M S Ramaiah Medical College 
Address  M S Ramaiah Medical College,New BEL Road,MSR Nagar,Mathikere, Bangalore.Karnataka- 560054 
Type of Sponsor  Private medical college 
 
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 Rahul Ramesh Pola  M S Ramaiah Medical College   Department of Anaesthesia, M S Ramaiah Medical College,,Mathikere,Bangalore 560054
Bangalore
KARNATAKA 
8495000133

rahulsaysthat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
M S Ramaiah Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5% lignocaine patch  the above medicated patch will be cut to the size of 6cm X 2cm and the adhesive tape removed and will be applied over the vein on the back of the hand 1 hour prior to placement of the intravenous canula 
Comparator Agent  Eutectic mixture of local anaesthesia   the above patch will be cut to the size of 6cm X 2cm and will be applied over the selected vein on the back of the hand 1 hour prior to the placement of intravenous canula  
Comparator Agent  Ketoprofen patch  the above patch will be cut to the size of 6cm X 2cm and will be applied over the selected vein on the back of the hand 1 hour prior to the placement of intravenous canula  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA-1 to ASA-3 patients undergoing elective surgeries planned under General Anaesthesia. 
 
ExclusionCriteria 
Details  1. Patients refusal to participate in the study. 2. Patients with documented allergy to the study drugs. 3. Patients with allergy to egg white. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess severity of pain on venous Cannulation among the 3 groups(Group Lidocaine, Group Ketoprofen and Group EMLA)  BASELINE  
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the severity of pain on injection of 20mg of 1
1% Propofol.
2.To observe the presence of Erythema, Induration or Blanching at the site of patch application after 6 hours of application. 
1 HOUR

6 HOURS  
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   01/05/2021 
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)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  THROUGH DIRECT EMAIL CONTACT

  6. For how long will this data be available start date provided 01-11-2023 and end date provided 01-11-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Peripheral Venous Cannulation (PVC) is an everyday practice in hospitals during which many patients experience pain and discomfort. It is a mandatory step during anaesthesia and in many other critical situations like resuscitation.Inadequate pain relief is not only unpleasant but may cause anxiety about further treatment deterring patients from seeking medical care in future.Topical anaesthetics applied locally to the vein before cannulation are non-invasive, well tolerated by patients and have been proven to be safe and efficacious.

Lidocaine is a synthetic amino ethylamide. It stabilizes the neuronal membrane by inhibiting ionic influxes required for the initiation and propagation of nerve impulses. A 5% lidocaine transdermal patch is available for topical analgesia. It comes as a single layer matrix patch which diffuses across the upper layers of the skin via passive diffusion from an area of high concentration to low concentration to produce an analgesic effect.

Ketoprofen is a propionic acid derivative and a non-steroidal anti-inflammatory drug (NSAID). It inhibits the activity of Cyclo-oxygenase (COX) 1 and 2 resulting in inhibition of prostaglandin and thrombaxane synthesis thereby decreasing the inflammatory response to cannulation and hence pain.Ketoprofen Transdermal patch when applied on the intact skin produces sufficient analgesia and has an advantage of minimizing thrombophlebitis due to its anti-inflammatory action.

Eutectic mixture of local anaesthetic (EMLA) Cream, a liquid emulsion is a eutectic mixture of the two amide local anaesthetics, namely Lidocaine 2.5% and Prilocaine 2.5%. When applied to the intact skin under occlusive dressing, EMLA cream releases lidocaine and prilocaine into the epidermal and dermal layers of the skin and provides analgesia by the accumulation of these anaesthetics in the vicinity of dermal pain receptors and nerve endings.A potential disadvantage of these topical agents could be the occurrence of erythema, induration or blanching at the site of their application.                                                                                                                                                                                                                      In the present study we seek to compare the analgesic efficacy of transdermal lidocaine 5% patch with transdermal ketoprofen patch and EMLA cream during PVC, as these modalities are easy to administer, non-invasive and with minimal adverse effects and drug interactions. 

 
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