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
|
|
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
|
|
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
- 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 - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - THROUGH DIRECT EMAIL CONTACT
- 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.
- 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. |