| CTRI Number |
CTRI/2024/02/062761 [Registered on: 16/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the two drugs - one applied on the skin and the other given in the vein - in post operative pain management in patients who underwent Laparoscpoic Appendicectomy |
|
Scientific Title of Study
|
To compare efficacy of transdermal Diclofenac (Nu Patch 200mg) with conventional analgesia in post operative pain management after Laparoscopic Appendicectomy - a Randomised Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rhythm Uppal |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, 590010
Department of General Surgery
rhythmuppal@gmail.com
Belgaum
KARNATAKA
590010
India |
| Phone |
9501903266 |
| Fax |
|
| Email |
rhythmuppal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Prashant Hombal |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, 590010
Department Of General Surgery
hombalp@yahoo.com
KARNATAKA
590010
India |
| Phone |
6364506981 |
| Fax |
|
| Email |
hombalp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rhythm Uppal |
| Designation |
Post Graduate |
| Affiliation |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, 590010
Department Of General Surgery
rhythmuppal@gmail.com
KARNATAKA
590010
India |
| Phone |
9501903266 |
| Fax |
|
| Email |
rhythmuppal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, KLE University, Belagavi |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, 590010 |
| 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 Rhythm Uppal |
KLE Dr. Prabhakar Kore Hospital And Medical Research Centre |
KLE Dr. Prabhakar Kore Hospital And Medical Research Centre,
Department Of General Surgery, Nehru Nagar, Belagavi, Karnataka, 590010
Belgaum
KARNATAKA |
9501903266
rhythmuppal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diclofenac |
Transdermal Diclofenac Patch containing 200mg Diclofenac has to be used for post operative pain management in patients undergoing Laparoscopic Appendicectomy.
Route of administration - Transdermal
Duration of intervention - 1 day |
| Comparator Agent |
Paracetamol |
Intravenous Paracetamol 1000mg as the analgesic agent in post operative pain management of Laparoscopic Appendicectomy patients.
Route of administration - Intravenous
Duration of administration - 1 day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing laparoscopic appendicectomy with 3 ports (two ports of 10mm at periumbilical region and Suprapubic region and one of 5mm at left iliac fossa)
2. Patients more than 18 years and equal to or less than 40 years
3. Patients with no comorbid condition
4. Patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Laparoscopic converted to open procedure
2. Patients allergic to Diclofenac or any other NSAIDS
3. Difference in number and location of port sites
4. Patients less than 18 years and more than 40 years
5. Patients with comorbid conditions
6. Patients with appendicular mass/abscess/peritonitis
7. Patients with renal diseases
8. Patients with associated conditions like- pelvic abscess/collection, Meckel’s diverticulitis, pelvic inflammatory disease, any other pelvic condition.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain management for 1 day |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post Operative pain management for 2-3 days |
2-3 days |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The Randomised Control Trial is going to be conducted for comparing the efficacy of Transdermal Diclofenac patch with the conventional analgesia that is Intravenous Paracetamol in post-operative pain management of patients undergoing Laparoscopic Appendicectomy. There will be two groups- 56 Control group and 56 Test Group. In the test group, the Transdermal Patch will be applied at the back on the non hairy skin at zero hour post-operatively and the patient will be given the Visual Analog Score to evaluate pain. If VAS > 4 then rescue analgesia (Intravenous Tramadol) will be given. The other group will receive Intravenous Paracetamol. The VAS will be measured at 0, 6, 12, 18, 24 hours. |