| 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
|
|
|
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
|
|
|
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 damageâ€. 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. |