| CTRI Number |
CTRI/2008/091/000216 [Registered on: 24/10/2008] |
| Last Modified On: |
26/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
To compare the effectiveness and safety of Inj Diclofenac 75mg/ml given intradeltoid with Injection Diclofenac 75mg/3ml given intragluteal in the management of postoperative pain. |
Scientific Title of Study
Modification(s)
|
A randomised comparative study evaluating the efficacy and tolerability of injection Diclofenac sodium 75mg/1ml given intradeltoid with injection Diclofenac sodium 75mg/3ml given intragluteal in the management of post operative pain. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
|
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Limited
Commerce House-1, Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
|
| Affiliation |
Vice President Medical Services |
| Address |
Troikaa Pharmaceuticals Limited
Commerce House - 1, Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
|
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Limited
Commerce House - 1, Satya Marg, Bodakdev
Ahmadabad
GUJARAT
380 054
India |
| Phone |
079-26856242 |
| Fax |
079-26856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Troikaa Pharmaceuticals Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Troikaa Pharmaceuticals Limited |
| Address |
Commerce House - 1, Satya Marg, Bodakdev |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR. COL. T. V. S. P. MURTHY |
Army Hospital R & R |
Professor, Neuroanaesthesiologist & Intensivist, Department of anesthesiology & Intensive Care,Army Hospital R & R, Delhi Cant-110010
New Delhi
DELHI |
(011) 2863 8260
tvspmurthy@yahoo.com |
| DR. B. M. SUBNIS |
Grant Medical College & Sir J. J. group of hospitals |
Dean, Professor & Head, Department of surgery,Grant Medical College, Sir J. J. group of hospitals, Byculla-400 008
Mumbai
MAHARASHTRA |
+91 22 23646332
022-23735599
bmsubnis@gmail.com |
| DR ANIL VARSHNEY |
R. G. Stone Urological Research Centre |
Chief Urologist, R. G. Stone Urological Research Centre,,F-12, East of Kailash-110065
New Delhi
DELHI |
011-41621000
011-26218743
drvarshney@rghospital.com |
| DR. C. V. PRADHAN |
Sancheti Institute for Orthopaedics & Rehabilitation |
Consultant Incharge, Emergency Trauma services,Sancheti Institute for Orthopaedics & Rehabilitation, 16, Shivaji Nagar-411 005
Pune
MAHARASHTRA |
+91(020) 25533333, 25533434
(020) 25533233
pradhanchetan@hotmail.com |
| DR. PRERANA SHROFF |
Seth G. S. Medical college and K. E. M Hospital |
Associate Professor, Department of anesthesiology,Seth G. S. Medical college and K. E. M Hospital, Acharya Donde Marg, Parel-400 012
Mumbai
MAHARASHTRA |
91-22-24136051, Extn. 7486
91-22-2414 3435
preranashroff@kem.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects, Seth G. S. Medical College & K. E. M. Hospital |
Approved |
| Ethics Committee of R. G. Stone Urological Research Institute |
Approved |
| Hospital Ethics Committee, Army Hospital R & R |
Approved |
| Independent Ethics Committee, Sancheti Institute for Orthopaedics & rehabilitation |
Approved |
| Institutional Ethics Committee, Grant Medical College & Sir J. J. group of Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Post Operative Pain , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Injection Diclofenac sodium 75 mg/ 1 ml |
75 mg given intra-deltoid repeated every 12 hours for 2 days. |
| Comparator Agent |
Injection Diclofenac sodium 75 mg/3 ml |
75 mg given intra-gluteal repeated every 12 hours for 2 days. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 18-65 years
2. Patients of both sexes
3. Patients with healthy deltoid/ gluteal muscle mass
4. Patients undergoing operative procedures requiring hospitalization for at least 48 hours with moderate to severe pain
5. Patients with moderate to severe pain at baseline (VAS 4 -10)
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years and above 65 years of age
2. OPD patients/ patients requiring hospitalization less than 48 hours
3. Patients with compromised renal function
4. Pregnant and lactating women
5. Patients with history of bronchial asthma, peptic ulceration, bronchitis
6. Patients with bleeding disorders
7. Mentally retarded patients
8. Unwilling patients
9. Patients with known hypersensitivity to diclofenac sodium any other NSAIDs or any component of either of the study formulations
10. Patients with mild baseline pain (1-3)
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Intensity of post operative pain as assessed by visual analogue scale (VAS) |
At the end of 1, 4, 8 and 12 hours as compared to basal after each dose. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Global efficacy by patients and investigator. |
End of Study (After 48 hrs) |
| Pain at the site of injection as assessed by visual analogue scale (VAS) |
At 1 hour and 12 hours after each dose. |
| Physicians evaluation of swelling, redness and induration at the site of injection |
After each dose |
| Systemic Adverse Reactions and Rescue Medication |
Upto 48 hours. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
16/12/2007 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Study has been published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Non steroidal anti inflammatory drugs are alternatives to opioids as sole analgesic after minor surgery or as adjuvant to opioid analgesics following major surgery. One of the most commonly used NSAID for postoperative pain is diclofenac. Currently injection diclofenac is available as a 3 ml formulation and needs to be given deep intra-muscular usually intra-gluteal. A new formulation of injection diclofenac with reduced injection volume (1ml) has recently become available for clinical practice. Due to a lower injection volume it can also be given intra-deltoid. The aim of the study is to compare the efficacy and safety of the newer 1 ml formulation of injection diclofenac with the existing formulation in the management of post operative pain. |