| CTRI Number |
CTRI/2024/01/061659 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
18/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of safety of transdermal ketoprofen and diclofenac patches in post-operative pain management |
|
Scientific Title of Study
|
Comparison of efficacy and safety of single dose transdermal ketoprofen and diclofenac patches in post-operative pain management in patients undergoing lower limb orthopedic procedures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavithira Sekar |
| Designation |
Associate Professor |
| Affiliation |
Sri Lalithambigai medical college |
| Address |
Department of Pharmacology,
Sri Lalithambigai Medical college and Hospital, Service Rd, Maduravoyal, Adayalampattu,
Chennai
TAMIL NADU
600095
India |
| Phone |
9940087476 |
| Fax |
|
| Email |
drpavithras06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavithira Sekar |
| Designation |
Associate Professor |
| Affiliation |
Sri Lalithambigai medical college |
| Address |
Department of Pharmacology,
Sri Lalithambigai Medical college and Hospital, Service Rd, Maduravoyal, Adayalampattu,
Chennai
TAMIL NADU
600095
India |
| Phone |
9940087476 |
| Fax |
|
| Email |
drpavithras06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavithira Sekar |
| Designation |
Associate Professor |
| Affiliation |
Sri Lalithambigai medical college |
| Address |
Department of Pharmacology,
Sri Lalithambigai Medical college and Hospital, Service Rd, Maduravoyal, Adayalampattu,
Chennai
TAMIL NADU
600095
India |
| Phone |
9940087476 |
| Fax |
|
| Email |
drpavithras06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Lalithambigai medical college and hospital, service road, Maduravoyal, Adayalampattu, chennai -600095
|
|
|
Primary Sponsor
|
| Name |
Sri Lalithambigai medical college |
| Address |
Service Rd, Maduravoyal,
Adayalampattu, Chennai, Tamil Nadu 600095
|
| 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 |
| DrPavithira |
Sri Lalithambigai medical college |
Department of Pharmacology, Service Rd, Maduravoyal, Adayalampattu,
Chennai
TAMIL NADU |
9940087476
drpavithras06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri lalithambigai 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 |
| Comparator Agent |
diclofenac 100 mg transdermal patch. |
35 patients assigned in Group D received transdermal diclofenac 100 mg. In the immediate postoperative period no other analgesics were given. To assess the postoperative pain visual analogue scale (VAS) were used. VAS score was recorded at 4,6,8,12 and 24 hours postoperatively. Sleep interference score was also recorded on 10 point scale that described how the pain had interfered with patient’s sleep during the first 24 hours. |
| Comparator Agent |
Ketoprofen 20 mg transdermal patch |
35 patients assigned in Group K received transdermal ketoprofen 20 mg.Two hours after administering the spinal anaesthesia, the corresponding transdermal patch was applied. The patch was applied to non- hairy areas of the body preferably in the upper chest or deltoid region. In the immediate postoperative period no other analgesics were given. VAS score was recorded at 4,6,8,12, and 24 hours postoperatively.Sleep interference score was also recorded that described how the pain had interfered with patient’s sleep during the first 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
who were all undergoing lower limb surgeries (ORIF). |
|
| ExclusionCriteria |
| Details |
pregnant or lactating mothers, patients on chronic pain treatment, patients with known allergy to the study drug, with any bleeding disorders, with history of impaired cognitive functions and history of alcohol and substance abuse. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative pain was taken in a visual analogue scale |
visual analogue scale (VAS) were used. VAS score was recorded at 4,6,8,12 and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep interference score was also recorded on a 10-point scale |
how the pain had interfered with patient’s sleep during the first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/02/2024 |
| 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="6"
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
|
Preoperatively demographic data like age, gender weight, BMI were noted. On the day of surgery patients were shifted to the operating room, standard monitors were applied, two wide bore intravenous cannula placed and spinal anesthesia were given. Two hours after administering the spinal anaesthesia, the corresponding transdermal patch was applied. The patch was applied to non- hairy areas of the body preferably in the upper chest or deltoid region. In the immediate postoperative period no other analgesics were given. To assess the postoperative pain visual analogue scale (VAS) were used. VAS score was recorded at 4,6,8,12, and 24 hours postoperatively. Sleep interference score was also recorded on a 10-point scale that described how the pain had interfered with patient’s sleep during the first 24 hours. |