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CTRI Number  CTRI/2024/10/075264 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pain management using transdermal Diclofenac, Ketoprofen and Lidocaine patch for patients undergoing modified radical mastectomy  
Scientific Title of Study   To compare the efficacy of transdermal diclofenac, ketoprofen and lidocaine patch in post operative pain outcome in modified radical mastectomy patients and consumption of opioid in first 24 hours via patient controlled analgesia pump 
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 Sonali Mittal 
Designation  Junior Resident 
Affiliation  Swami Rama Himalayan University 
Address  Department Of anaesthesiology Himalayan Institute Of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Department Of anaesthesiology Himalayan Institute Of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Dehradun
UTTARANCHAL
248140
India 
Phone  7830312121  
Fax    
Email  smittal1996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gurjeet Khurana 
Designation  Head Of Department and Professor 
Affiliation  Swami Rama Himalayan University 
Address  Department Of anaesthesiology Himalayan Institute Of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Department Of anaesthesiology Himalayan Institute Of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Dehradun
UTTARANCHAL
248140
India 
Phone  9410539190  
Fax    
Email  gurjeetkhurana@srhu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sonali Mittal 
Designation  Junior Resident 
Affiliation  Swami Rama Himalayan University 
Address  Department Of anaesthesiology Himalayan Institute Of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Department Of anaesthesiology Himalayan Institute Of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun
Dehradun
UTTARANCHAL
248140
India 
Phone  7830312121  
Fax    
Email  smittal1996@gmail.com  
 
Source of Monetary or Material Support  
Anaesthesia Department room number 103 first floor himalayan institute of medical sciences doiwala dehradun 248140 
 
Primary Sponsor  
Name  Swami Rama Himalayan University 
Address  Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Jolly Grant, Dehradun, 248140 
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 Sonali Mittal  Himalayan Institute of Medical Sciences   Department of anesthesiology, first floor Main building, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, UTTARANCHAL
Dehradun
UTTARANCHAL 
7830312121

smittal1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SWAMI RAMA HIMALAYAN UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ketoprofen Patch  GROUP K- Ketoprofen Transdermal Patch Dose- 30mg Frequency- applied 1 hour prior to surgery and changed after 12 hours Duration of action of one patch is 12 hours 
Intervention  Lidocaine Patch  GROUP L- Lignocaine Transdermal Patch Dose- 350mg Frequency- applied 1 hour prior to surgery and changed after 12 hour. Duration of action of one patch is 12 hours 
Comparator Agent  NUPATCH -Diclofenac Patch  GROUP D -Diclofenac Transdermal Patch Dose- 75mg Frequency-applied 1 hour prior to surgery and changed after 12 hours Duration of action of one patch is 12 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Patients undergoing modified radical mastectomy
Patients giving written consent
ASA 1, 2 and 3
 
 
ExclusionCriteria 
Details  Patients operated for benign breast disease
Patients undergoing repeat surgery or reconstructive breast surgery
Allergic to Diclofenac, Ketoprofen or Lignocaine or any other drug used in the study


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the numerical rating score (NRS) score between diclofenac, ketoprofen and lidocaine patch groups and to evaluate the post operative 24 hour intravenous fentanyl consumption through Patient controlled analgesia pump  1 hour pre induction to 24 hour post operative 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and document the complications and side effects of diclofenac, ketoprofen and lidocaine patch for post operative analgesia for 24 hours.  1 hour pre induction to 24 hour post operative 
 
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)   12/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  12/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
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  

Breast cancer treatment is multidisciplinary including surgical, hormonal therapy, targeted drug therapy, radiotherapy, chemotherapy and immunotherapy. Modified Radical Mastectomy (MRM) is a procedure in which the entire breast is removed including the skin, nipple, areola and most axillary lymph nodes, except the pectoralis major muscle which is spared. Most common complication in patients undergoing modified radical mastectomy is pain. In 2020 definition of pain has been revised by International Association for Study of Pain (IASP) as “an unpleasant sensory and emotional experience associated with or resembling that associated with actual or potential tissue damage”. Post MRM pain can be Axillary, chest, shoulder and arm pain, which if left untreated can turn into chronic pain. This is described as post mastectomy pain syndrome (PMPS). Persistent pain in post operative period affects 20-50% of mastectomy patients which in turn affects quality of life of the patient thereafter. Pathophysiology of pain is mainly unrelieved inflammation. Reducing post operative pain can improve the quality of life for which different pain modalities can be used including intravenous (iv) opioids, non-steroidal anti inflammatory drugs (NSAIDS), antiepileptics, antidepressants, blocks. Regional nerve blocks show good efficacy in pain management but the availability of ultrasound limits the use of blocks. Opioid induced hyperalgesia is a sensitisation process whereby opioids, paradoxically causes increased pain sensitivity. In recent advances for multimodal analgesia, opioid free analgesia is produced to avoid opioid related side effects. Non opioid analgesics include NSAIDS, Selective Serotonin reuptake inhibitors, Tricyclic antidepressants, Salicylates, etc .Transdermal drug delivery system is painless method of delivering drugs systematically by applying a drug formulation onto intact and healthy skin. The drug initially penetrates through the stratum corneum and then passes through the deeper epidermis and dermis without drug accumulation in the dermal layer. When drug reaches the dermal layer, it becomes available for systemic absorption via the dermal microcirculation. This route has many advantages including non invasiveness, ease of access and the pharmacokinetics of the drug is more uniform, thus minimizing the risk of toxic side effects. Transdermal drugs bypass the first-pass metabolism of the liver, protecting it from damage 

By the end of study we will be able to find out the efficacy of lignocaine patch for post operative pain management in modified radical mastectomy patients.

 
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